Clinical Trials Register

Summary
EudraCT Number:	2020-003229-47
Sponsor's Protocol Code Number:	KEEP-ON
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-12-17
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

Spain - AEMPS

A.2

EudraCT number

2020-003229-47

A.3

Full title of the trial

Phase III, multicenter, open-label, randomized clinical trial to evaluate efficacy of Sodium Zirconium Cyclosilicate (Lokelma) compared to standard of care to manage hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history

Ensayo Clínico fase III, multicéntrico, abierto y aleatorizado para evaluar la eficacia del tratamiento con Ciclosilicato de Sodio y Zirconio (Lokelma), comparado con la terapia estándar, para el manejo de la hiperpotasemia en pacientes con enfermedad renal crónica (ERC) e historial de insuficiencia cardiaca

A.3.1

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

Keeping RAASi treatment with optimal potassium control

Manteniendo el tratamiento con iSRAA con un control óptimo de potasio

A.4.1

Sponsor's protocol code number

KEEP-ON

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	Instituto de Investigación Sanitaria INCLIVA
B.1.3.4	Country	Spain
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	AstraZeneca Farmacéutica Spain, S.A.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Instituto de Investigación Sanitaria INCLIVA
B.5.2	Functional name of contact point	Subdirectora Científica
B.5.3	Address:
B.5.3.1	Street Address	Avd. Menédez Pelayo 4 acc
B.5.3.2	Town/ city	Valencia
B.5.3.3	Post code	46010
B.5.3.4	Country	Spain
B.5.4	Telephone number	0034961973536
B.5.5	Fax number	0034961973540
B.5.6	E-mail	gestioncientifica@incliva.es

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	Lokelma
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca Spain, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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 oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ZIRCONIUM CYCLOSILICATE
D.3.9.3	Other descriptive name	SODIUM ZIRCONIUM CYCLOSILICATE
D.3.9.4	EV Substance Code	SUB180392
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
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)	No
	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: 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	Lokelma
D.2.1.1.2	Name of the Marketing Authorisation holder	AstraZeneca Spain, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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 oral suspension
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM ZIRCONIUM CYCLOSILICATE
D.3.9.3	Other descriptive name	SODIUM ZIRCONIUM CYCLOSILICATE
D.3.9.4	EV Substance Code	SUB180392
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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)	No
	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

Hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history

Hiperpotasemia en pacientes con enfermedad renal crónica (ERC) e insuficiencia cardiaca

E.1.1.1

Medical condition in easily understood language

Hyperkalemia in patients with chronic kidney disease (CKD) and heart failure history

Hiperpotasemia en pacientes con enfermedad renal crónica (ERC) e insuficiencia cardiaca

E.1.1.2

Therapeutic area

Diseases [C] - Symptoms and general pathology [C23]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	LLT
E.1.2	Classification code	10020647
E.1.2	Term	Hyperkalemia
E.1.2	System Organ Class	100000004861

E.1.2 Medical condition or disease under investigation

E.1.2	Version	23.1
E.1.2	Level	PT
E.1.2	Classification code	10064848
E.1.2	Term	Chronic kidney disease
E.1.2	System Organ Class	10038359 - Renal and urinary disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10019285
E.1.2	Term	Heart failure, unspecified
E.1.2	System Organ Class	100000004849

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To analyze the proportion of patients achieving serum potassium of < 5.5 mEq/L with Sodium Zirconium Cyclosilicate (SZC) versus discontinuation of RAASi and/or MRA in patients with hyperkalemia and non dialysis CKD and heart failure history.

Analizar la proporción de pacientes que logran un potasio sérico de < 5,5 mEq/L con Ciclosilicato de Sodio y Zirconio (CSZ) frente a la interrupción de iSRAA y/o ARM en pacientes con hiperpotasemia y antecedentes de ERC no dializada e insuficiencia cardiaca.

E.2.2

Secondary objectives of the trial

1) To determine if the percentage of patients achieving serum potassium < 5 mEq/L at two of the four temporal points is not inferior in Lokelma compared to RAASi / MRA discontinuation or downtitration.
2) To determine the number of patients treated with Lokelma who effectively reduce serum potassium > 20 % over the baseline at days 7, 30, 60 and 90 compared to RAASi / MRA discontinuation or downtitration.
3) To compare the percentage of patients achieving serum potassium below 5, 5.5, 6, 6.5 mEq/L at days 7, 30, 60 and 90 in both groups.
4) To compare the need for additional treatments for serum hyperkalemia between both groups during the study (potassium binding resins, adding or increasing loop diuretics if hypervolemia).
5) To compare albuminuria changes at 90 days from baseline.

1) Determinar si el porcentaje de pacientes que logran un potasio sérico < 5 mEq/L en dos de los cuatro puntos temporales no es inferior en Lokelma en comparación con la interrupción de iSRAA / MRA o la reducción de la dosis.
2) Determinar el número de pacientes tratados con Lokelma que reducen efectivamente el potasio sérico > 20 % con respecto al valor basal en los días 7, 30, 60 y 90 en comparación con la interrupción de iSRAA / MRA o la reducción de la dosis.
3) Comparar el porcentaje de pacientes que logran reducir el potasio sérico por debajo de 5, 5,5, 6, 6,5 mEq/L en los días 7, 30, 60 y 90 en ambos grupos.
4) Comparar la necesidad de tratamientos adicionales para la hiperpotasemia sérica entre ambos grupos durante el estudio (resinas fijadoras de potasio, adición o aumento de diuréticos de asa si hay hipervolemia).
5) Comparar los cambios en la albuminuria a los 90 días desde el inicio del estudio.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patients must present serum potassium levels of 5.5-6.5 mEq/L at the day of inclusion.
2. Provision of patient or legal representative informed consent prior to any study specific procedures.
3. Previous history of heart failure (cardiorenal syndrome) established as a HF diagnose which has been present for at least 3 months.
4. Individuals receiving background standard of care for HF and treated according to locally recognized guidelines. Specific treatment should include RAASi and/or MRA treatment at first consultation and at least should have been stable for ≥ 4 weeks at maximum tolerated doses.
5. Patients with CKD not on dialysis (Stages 2-5: estimated glomerular filtration rate (eGFR) between 15-60 ml/min/1,73m2 or eGFR between 60-90 ml/min/ 1.73 m2 with albuminuria/creatinuria (> 30 mg/g) in the previous three months). The estimated GFR can be reported by the laboratory or calculated by the researcher with serum creatinine, age, and sex (CKD-EPI equation).
6. At least 18 years at the time of signing ICF.
7. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.

1. Los pacientes deben presentar niveles de potasio sérico de 5,5-6,5 mEq/L el día de la inclusión.
2. Obtención del consentimiento informado del paciente o representante legal antes de cualquier procedimiento específico del estudio.
3. Historia previa de insuficiencia cardiaca (síndrome cardiorrenal) establecida como diagnóstico de IC que haya estado presente durante al menos 3 meses.
4. Individuos que reciban el tratamiento estándar para la IC y sean tratados de acuerdo con las directrices locales. El tratamiento específico debe incluir tratamiento con iRSAA y/o ARM en la primera consulta y al menos debe haber estado estable durante ≥ 4 semanas a dosis máximas toleradas.
5. Pacientes con ERC no en diálisis (Estadios 2-5: tasa de filtración glomerular estimada (TFGe) entre 15-60 ml/min/1,73m2 o TFGe entre 60-90 ml/min/1,73m2 con albuminuria/creatinuria (> 30 mg/g) en los tres meses previos). La TFG estimada puede ser informada por el laboratorio o calculada por el investigador con la creatinina sérica, la edad y el sexo (ecuación CKD-EPI).
6. Tener al menos 18 años en el momento de firmar el CI.
7. Prueba de embarazo negativa (orina o suero) para las mujeres en edad fértil.

E.4

Principal exclusion criteria

1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
2. Previous enrollment or randomization in the present study.
3. HF due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy or uncorrected primary valvular disease.
4. Current acute decompensated HF, hospitalization due to decompensated HF, myocardial infarction, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrollment.
5. Coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting or valvular repair/replacement within 12 weeks prior to enrollment or planned to undergo any of these operations after randomization).
6. Implantation of a Cardiac Resynchronization Therapy (CRT) device or Implantable Cardioverter Defibrillator (ICD) within 12 weeks prior to enrollment or intent to perform atrial fibrillation ablation or to implant a CRT or ICD device.
7. Previous cardiac transplantation or implantation of a ventricular assistance device or similar device, or transplantation or implantation expected after randomization
8. Oropharingeal dysfunction that precludes normal swallow.
9. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using a highly effective contraceptive method.
10. Patients with amputated limbs or pacemaker devices will be excluded of bioimpedance analysis.
11. Participation in another clinical study with an investigational product during the last 6 months.
12. Patients with a known hypersensitivity to SZC or any of the excipients of the product.
13. Treated with potassium binding resins such as sodium polystyrene sulfonate (SPS; e.g. Kayexalate®) or calcium polystyrene sulfonate (CPS; e.g. Resonium®) or the cation exchange polymer, patiromer sorbitex calcium (Veltassa®), within 7 days prior to the first dose of study drug.
14. Judgment by the investigator that the subject should not participate in the study if the subject is unlikely to comply with study procedures, restrictions and requirements.
15. Subjects with a family history of long QT syndrome, presence of cardiac arrhythmias or conduction defects that require immediate treatment, or a QTc (corrected QT interval) of ≥ 550 msec.
16. History of QT prolongation associated with other medications that required discontinuation of that medications.
17. Symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.

1. Participación en la planificación y/o realización del estudio (aplica tanto al personal investigador como al personal del centro).
2. Reclutamiento o aleatorización previa en el presente estudio.
3. IC debida a una miocardiopatía restrictiva, miocarditis activa, pericarditis constrictiva, miocardiopatía hipertrófica (obstructiva) o valvulopatía primaria no corregida.
4. IC aguda descompensada actual, hospitalización por IC descompensada, infarto de miocardio, angina inestable, accidente cerebrovascular o ataque isquémico transitorio en las 12 semanas anteriores a la inclusión.
5. Revascularización coronaria (intervención coronaria percutánea o injerto de derivación arterial coronaria o reparación/reemplazo valvular dentro de las 12 semanas anteriores a la inclusión o que se planea someter a cualquiera de estas operaciones después de la aleatorización).
6. Inserción de un dispositivo de Terapia de Resincronización Cardiaca (TRC) o Desfibrilador Cardioversor Implantable (DCI) en las 12 semanas anteriores a la inclusión o intención de realizar una ablación de fibrilación auricular o de implantar un dispositivo TRC o DCI.
7. Trasplante cardiaco previo o inserción de un dispositivo de asistencia ventricular o dispositivo similar, o trasplante o inserción prevista después de la aleatorización
8. Disfunción orofaríngea que impida la deglución normal.
9. Mujeres embarazadas, en periodo de lactancia o con intención de quedarse embarazadas, o en edad fértil que no utilicen un método anticonceptivo de alta eficacia.
10. Los pacientes con extremidades amputadas o dispositivos de marcapasos serán excluidos del análisis de bioimpedancia.
11. Participación en otro estudio clínico con un producto en investigación durante los últimos 6 meses.
12. Pacientes con hipersensibilidad conocida a Lokelma o a cualquiera de los excipientes del producto.
13. Tratados con resinas de unión de potasio como el poliestireno sulfonato de sodio (SPS; por ejemplo, Kayexalate®) o el poliestireno sulfonato de calcio (CPS; por ejemplo, Resonium®) o el polímero de intercambio catiónico, patiromer sorbitex calcio (Veltassa®), en los 7 días anteriores a la primera dosis del fármaco del estudio.
14. El investigador considera que el sujeto no debe participar en el estudio porque es improbable que cumpla con los procedimientos, restricciones y requisitos del estudio.
15. Sujetos con antecedentes familiares de síndrome de QT largo, presencia de arritmias cardiacas o defectos de conducción que requieran tratamiento inmediato, o un QTc (intervalo QT corregido) de ≥ 550 mseg.
16. Antecedentes de prolongación del QT asociada a otros medicamentos que hayan requerido la interrupción de los mismos.
17. Fibrilación auricular sintomática o no controlada a pesar del tratamiento, o taquicardia ventricular sostenida asintomática. Se permiten los sujetos con fibrilación auricular controlada mediante medicación.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients achieving serum potassium < 5.5 mEq/L at three or all timepoints in both groups.

Porcentaje de pacientes que logran un potasio sérico < 5,5 mEq/L en tres o todos los puntos de tiempo en ambos grupos.

E.5.1.1

Timepoint(s) of evaluation of this end point

7, 30, 60 or 90 days after randomization

7, 30, 60 o 90 días tras la aleatorización

E.5.2

Secondary end point(s)

1) Percentage of patients achieving serum potassium < 5 mEq/L at two of the four temporal points in both groups.
2) Number of patients treated with Lokelma with reduction of serum potassium > 20% after baseline in each time point.
3) Percentage of patients achieving serum potassium below 5, 5.5, 6, 6.5 mEq/L in each time point.
4) Percentage of patients requiring additional treatments for hyperkalemia in both groups (potassium binding resins, adding or increasing loop diuretics) or discontinuation of RAASi and/or MRA in Lokelma group.
5) Mean change in the urine albumin-to-creatinine ratio (UACR) at 90 days from baseline in patients treated with SZC compared to RAASi / MRA discontinuation or downtitration.

1) Porcentaje de pacientes que logran un potasio sérico < 5 mEq/L en dos de los cuatro puntos temporales en ambos grupos.
2) Número de pacientes tratados con Lokelma con reducción del potasio sérico > 20% después de la línea de base en cada punto temporal.
3) Porcentaje de pacientes que logran un potasio sérico inferior a 5, 5,5, 6, 6,5 mEq/L en cada punto temporal.
4) Porcentaje de pacientes que requirieron tratamientos adicionales para la hiperpotasemia en ambos grupos (resinas fijadoras de potasio, adición o aumento de diuréticos de asa) o interrupción de iSRAA y/o ARM en el grupo Lokelma.
5) Cambio medio en la relación albúmina-creatinina en orina (UACR) a los 90 días desde el inicio en los pacientes tratados con SZC en comparación con la interrupción o reducción del iSRAA / MRA.

E.5.2.1

Timepoint(s) of evaluation of this end point

7, 30, 60 or 90 days after randomization

7, 30, 60 o 90 días tras la aleatorización

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

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

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)

Yes

E.7.4

Therapeutic use (Phase IV)

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

práctica clínica habitual

standard of care

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in 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

LSLV

UVUP

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)

Yes

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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)

standard of care

práctica clínica habitual

G. Investigator Networks to be involved in the Trial

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-12-16

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

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