Clinical Trials Register

Summary
EudraCT Number:	2012-005335-83
Sponsor's Protocol Code Number:	OUS-PTx-01
National Competent Authority:	Norway - NOMA
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-12-12
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Norway - NOMA

A.2

EudraCT number

2012-005335-83

A.3

Full title of the trial

A Randomized Open-label Study:
Efficacy and safety of basiliximab combined with tacrolimus, mycophenolate and low-dose corticosteroids vs thymoglobulin, tacrolimus, mycophenolate and high-dose corticosteroids in Pancreatic Allograft Recipients

En randomisert, åpen studie:
Effekt og sikkerhet av basiliximab kombinert med tacrolimus, mycophenolate og lav-dose corticosteroider vs thymoglobulin, tacrolimus, mycophenolate og høy-dose corticosteroider hos Pancreatic Allograft Recipienter

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Comparison between a low-dose and a high-dose immunosuppressive regimen in pancreas transplantation

Sammenligning av lav-dose og høy-dose immunhemmende behandling ved pancreas transplantasjon

A.3.2

Name or abbreviated title of the trial where available

The Norwegian pancreas-Tx study

Den norske pancreas-Tx studien

A.4.1

Sponsor's protocol code number

OUS-PTx-01

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Oslo University Hospital Rikshospitalet
B.1.3.4	Country	Norway
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Oslo University Hospital Rikshospitalet
B.4.2	Country	Norway
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Oslo University Hospital Rikshospitalet
B.5.2	Functional name of contact point	Ole Øyen
B.5.3	Address:
B.5.3.1	Street Address	Sognsvannsv. 20
B.5.3.2	Town/ city	Oslo
B.5.3.3	Post code	0027
B.5.3.4	Country	Norway
B.5.4	Telephone number	4723070686
B.5.5	Fax number	4723070510
B.5.6	E-mail	ole.oyen@rikshospitalet.no

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Simulect
D.2.1.1.2	Name of the Marketing Authorisation holder	Novartis Europharm Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder and solvent for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	Yes
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Solu-Medrol
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratórios Pfizer, Lda., Porto Salvo, Portugal
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 3
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Prednisolon
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 4
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Thymoglobuline
D.2.1.1.2	Name of the Marketing Authorisation holder	Genzyme Europe B.V., DD NAARDEN, Alankomaat
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	Yes
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 5
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Solu-Medrol
D.2.1.1.2	Name of the Marketing Authorisation holder	Laboratórios Pfizer, Lda., Porto Salvo, Portugal
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Powder for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 6
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Prednisolon
D.2.1.1.2	Name of the Marketing Authorisation holder	Oy Leiras Finland Ab, HELSINKI, Suomi
D.2.1.2	Country which granted the Marketing Authorisation	Norway
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The only indication for pancreas-transplantation (PTx) is advanced and/or badly controlled diabetes mellitus. Patients who have developed renal insufficiency due do diabetic nephropathy may be candidates for combined kidney- and pancreas-transplantation (SPK). While patients with "brittle diabetes" (without kidney failure), involving severe hypoglycemic episodes and "unawareness", may be candidates for solitary PTx. Anyway, high-levelled immunosuppression will be needed after PTx/SPK.

Den eneste indikasjonen for pancreas-transplantasjon (PTx) er langtkommen/dårlig regulert diabetes mellitus. Pasienter som har utviklet diabetisk nyresvikt kan være kandidater for kombinert nyre- og pancreas-Tx (SPK). Mens "skjøre" diabetes-pasienter, uten nyresvikt, men med alvorlige hypoglykemiske episoder, kan tilbys solitær PTx. Uansett vil høygradig immunsuppresjon være nødvendig etter PTx/SPK.

E.1.1.1

Medical condition in easily understood language

Patients with advanced or badly controlled diabetes may be candidates for pancreas transplantation (Tx). If complicated with renal insufficiency, combined kidney and pancreas-Tx may be offered.

Pasienter med alvorlig eller lanktkommen sukkersyke kan tilbys bukspyttkjertel-transplantasjon (Tx). Ved kompliserende nyresvikt kan det være aktuelt med kombinert nyre- og bukspyttkjertel-Tx.

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10052278
E.1.2	Term	Renal and pancreas transplant
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Several studies have shown acceptable results after Pancreas transplantation (PTx) by substituting ATG with basiliximab, which is considered to convey a considerably lower number of adverse events. However, the issue of ATG vs basiliximab in PTx has not yet been solved. The potential advantages of reducing the overall cortiocosteroid (CS) load is obvious, as CS is a well-known pro-diabetic agent and causes severe long term adverse effects. On this background, we intend to investigate a PTx low-grade immunosuppressive protocol, with Basiliximab and low-dose CS versus the conventional protocol with ATG and high-dose CS.
The primary aim will be to monitor the incidence of rejections, with particular attention to the low-immunosppressive arm. Furtehermore, we will look for a potential benefit regarding the rate of surgical complications in the low-immunosppressive arm.

Høygradig immunsuppresjon (IS) ved PTx er antatt å være medvirkende til den høye raten av kirurgiske komplikasjoner/reoperasjoner (ca. 30% av pasientene). Høygradig IS er åpenbart relatert til de realtivt betydelige infeksiøse komplikasjonene ved PTx. Forbedret overvåkning av rejeksjoner, ved hjelp av endoskopiske, transduodenale biopsier av pancreas-transplantatet (EUSBP), vil kunne legge grunnlaget for en mer lavgradig IS protokoll/arm. Ny kirurgisk PTx-teknikk med enteroanastomose mot nativ duodenum har muliggjort disse biopsiene. Det vil tas protokoll-biopsier etter 3 uker, 6 uker og 1 år, samt indikasjonsbiopsier ved mistanke om rejeksjon.
Studien vil bidra til å belyse spørsmålet om IS induksjonsbehandling ved PTx: ATG vs Basiliximab.
De primære målene vil således være å overvåke rejeksjonsraten, særlig mhp forsøksarmen, og se etter mulig effekt på komplikasjonsraten

E.2.2

Secondary objectives of the trial

• Compare the number and severity of rejection episodes in the pancreas allograft to
the ones occurring in the kidney allograft (SPK), and the ones diagnosed by the
duodenal segment biopsies.
• Compare pancreas graft survival between the study groups.
• Monitor kidney (and pancreas) graft survival in SPK.
• Compare patient survival between the study groups.
• Compare the incidence of non-surgical complications (infections, cardial complications,
pulmonary complications and neurological complications).
• Analyse possibly useful non-invasive markers of rejection (amylase, C-peptide etc).

• Sammenligne rejeksjoner (antall/grad) i simultane biopsier av pancreas, duodenal-
segment og nyre fra samme pasient.
• Sammenligne pankreas graft survival mellom gruppene.
• Sammenligne nyre- og pancreas graft survival ved SPK.
• Sammenligne pasient survival mellom gruppene.
• Sammenligne incidensen av ikke-kirurgiske komplikasjoner (infeksjoner, cardiale
komplikasjoner, pulmonale komplikasjoner og neurologiske komplikasjoner).
• Studere potensielt anvendbare non-invasive rejeksjonsmarkører (amylase, C-peptide etc)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Age ≥18 years
- Patients who receive a primary or secondary pancreas transplant, with or without a
simultaneous kidney transplant (SPK).
- Women who are of childbearing potential must have a negative serum pregnancy test at
baseline.
- Operability has to be ascertained by preop. examination, performed by nephrologist,
transplant surgeon and anaesthesiologist.
- Signed and dated informed consent form.

- Alder ≥18 år
- Pas. som skal gjennomgå en 1. eller 2. gangs Pancreas-Tx, med eller uten samtidig nyre-
Tx (SPK).
- Kvinner med gaviditetspotensiale må få påvist negativ Gravi-test ved baseline.
- Operabilitet må sikres ved preop. undersøkelse, gjennomført av nefrolog, Tx-kirurg og
anestesiolog.
- Signert og datert pasient-informasjon/samtykke-skjema.

E.4

Principal exclusion criteria

- Evidence of systemic infection.
- Presence of unstable cardiovascular disease.
- Malignancy < 5 years prior to entry into the trial (with the exception of adequately treated
basal cell or squamous cell carcinomas of the skin).
- Panel-reactive antibodies (PRA) > 20% or the presence of donor-specific antigens (DSA).
- Use of investigational agents <1 month prior to entry into the trial.
- Any positive test for HBV, HBC or HIV.

- Tegn på systemisk, aktiv infeksjon.
- Tegn på ustabil cardiovasculær sykdom.
- Malignitet < 5 år før studie-inklusjon (med unntak av adekvat behandlet basalcelle- eller
plateepitel-carcinom i hud).
- Panel-reaktive antistoffer (PRA) > 20% eller påviste donor-spesifikke antistoffer (DSA).
- Bruk av studie-medisiner <1 mnd før studie-inklusjon.
- Enhver positiv test for HBV, HBC eller HIV.

E.5 End points

E.5.1

Primary end point(s)

1. The incidence of acute rejection episodes at 6, 12, 36 and 60 months after pancreas transplantation, between two quadruple immunosuppressive regimens; basiliximab combined with tacrolimus, mycophenolate and low-dose corticosteroids vs thymoglobulin, tacrolimus, mycophenolate and high-dose corticosteroids. The incidence of rejection is defined as the fraction of patients in which rejections episodes (one or more) hve been proven by biopsies. For SPK rejection in either organ, pancreas or kidney, counts.
2. The incidence of surgical complications, involving reoperations and reinterventions (fraction of patients with one or more).

1. Incidensen av akutte rejeksjoner bedømt etter pancreas-transplantasjon, mellom to quadruple immunosuppressive regimer; basiliximab kombinert med tacrolimus, mycophenolate og lav-dose corticosteroider vs thymoglobulin, tacrolimus, mycophenolate og høy-dose corticosteroider. Incidensen av rejeksjoner er definert som andelen av pasienter med biopsiverifisert rejeksjon (en eller flere) i ett eller flere organer (SPK).
2. Incidensen av kirurgiske komplikasjoner, som medfører reoperasjon eller reintervensjon (andel pasienter med en eller flere).

E.5.1.1

Timepoint(s) of evaluation of this end point

1. Evaluated 6, 12, 36 and 60 months post-Tx.
2. Evaluated 3 months post-Tx.

1. Bedømt 6, 12, 36 and 60 mnd post-Tx.
2. Bedømt 3 mnd post-Tx.

E.5.2

Secondary end point(s)

1. The number and severity of rejection episodes in the pancreas allograft compared to the
ones occurring in the kidney allograft (SPK), and the ones diagnosed by the duodenal
segment biopsies.
2. Pancreas graft survival.
3. Kidney- (and pancreas) graft survival in SPK.
4. Patient survival.
5. The incidence of non-surgical complications (infections, cardial complications, pulmonary
complications and neurological complications).
6. Non-invasive markers of rejection (amylase, C-peptide etc).

1. Rejeksjoner (antall/grad) sammenlignet mellom simultane biopsier av pancreas,
duodenal-segment og nyre fra samme pasient.
2. Pankreas graft survival.
3. Nyre- (og pancreas graft) survival ved SPK.
4. Pasient survival.
5. Incidensen av ikke-kirurgiske komplikasjoner (infeksjoner, cardiale
komplikasjoner, pulmonale komplikasjoner og neurologiske komplikasjoner).
6. Non-invasive rejeksjonsmarkører (amylase, C-peptide etc).

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Evaluated 12 months post-Tx.
2. Evaluated 12, 36 and 60 months post-Tx.
3. Evaluated 12, 36 and 60 months post-Tx.
4. Evaluated 12, 36 and 60 months post-Tx.
5. Evaluated 12 and 60 months post-Tx.
6. Evaluated 12 months post-Tx (by blood samples taken daily for the first 14 days,
thereafter 3 times/week until week 10.

1. Bedømt 12 mnd post-Tx.
2. Bedømt 12, 36 and 60 mnd post-Tx.
3. Bedømt 12, 36 and 60 mnd post-Tx.
4. Bedømt 12, 36 and 60 mnd post-Tx.
5. Bedømt 12 and 60 mnd post-Tx.
6. Bedømt 12 mnd post-Tx (basert på blodprøver tatt daglig de første 14 dager,
deretter 3 ganger pr. uke, inntil uke 10.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

Yes

E.6.3

Therapy

Yes

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

Yes

E.6.13.1

Other scope of the trial description

Explore potential pancreas rejection markers.

Utforske potensielle markører for pancreas-rejeksjon.

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

E.7.4

Therapeutic use (Phase IV)

Yes

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Konv. høy-dose IS: Thymoglobulin, Tacrolimus, Mycophenolate og HD-Corticosteroider

Conv. high-dose IS: Thymoglobulin, Tacrolimus, Mycophenolate and HD-Corticosteroids

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

F.1.3.1

Number of subjects for this age range:

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

Ingen

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2013-02-15

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-04-05

P. End of Trial
P.	End of Trial Status	Ongoing

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IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
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