E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023438 |
E.1.2 | Term | Kidney transplant |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective of this study is to evaluate the efficacy and safety of alefacept in a kidney transplant population. Data suggests that 12 weeks of treatment with alefacept in combination with tacrolimus, mycophenolate mofetil (MMF) and steroids may be more effective than and as safe as a combination therapy of tacrolimus with MMF and steroids. Effectiveness will be measured as the occurrence of and time to biopsy proven acute rejection at six months assessed locally. |
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E.2.2 | Secondary objectives of the trial | |
E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
PHARMACOKINETICS OF ALEFACEPT IN DE NOVO KIDNEY TRANSPLANT RECIPIENTS Pharmacokinetic Sub-Study of the Protocol 0485-CL-E201 This sub-study is planned in a subgroup of subjects to obtain information on the PK of alefacept in de novo kidney transplant recipients. PK will be evaluated in a sub-study in a subgroup of 20 subjects (alefacept arm). |
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E.3 | Principal inclusion criteria |
Subject is eligible for the study if all of the following apply: 1. Subject with end stage kidney disease who is a suitable candidate for primary kidney transplantation or re-transplantation. 2. Male or female subject at least 18 years of age and younger than 65 years. 3. Subject receiving a kidney transplant from a non-human leukocyte antigen (non-HLA) identical living donor or an HLA identical/non-HLA identical deceased donor between 5 and 59 years of age with compatible AB0 blood type. 4. Female subjects of childbearing potential must have a negative serum pregnancy test at enrollment and must agree to maintain effective birth control during the study. Effective birth control is defined as surgically sterilized, hormonal contraception or total abstinence at the discretion of the investigator in cases where age, career, lifestyle or sexual orientation ensures compliance of the subject. 5. Subject has been fully informed and has given written informed consent. Subject unable to write and/or read but who fully understands the oral information given by the investigator (or nominated representative) has given oral informed consent witnessed in writing by an independent person.
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E.4 | Principal exclusion criteria |
Subject will be excluded from participation if any of the following apply: 1. Subject has a PRA grade > 20% in the previous 6 months and/or had had a previous graft survival shorter than 1 year due to immunological reasons. 2. Subject has received a kidney transplant from a non-heart beating donor. 3. Subject has received a kidney from a 50 - 59 year old donor with two of the following three factors: history of hypertension, cerebrovascular accident as cause of death, final pre-procurement serum creatinine >1.5 mg/dL (United Network for Organ Sharing UNOS expanded criteria donor). 4. Subject has previously received or is receiving an organ transplant other than kidney. 5. Cold ischemia time of the donor kidney is ≥ 30 hours. 6. Subject is pregnant or breastfeeding. 7. Subject has significant liver disease, defined as having continuously elevated AST and/or ALT levels greater than 2 times the upper value of the normal range. 8. Subject has known hypersensitivity to alefacept, tacrolimus, macrolide antibiotic, mycophenolate mofetil, corticosteroids or any of the product excipients. 9. Subject has received intravenous immunoglobulin (IVIG) therapy in the three months prior to first dose of study drug. 10. Subject requires initial sequential or parallel therapy with immunosuppressive antibody preparation. 11. Subject requires ongoing dosing with a systemic immunosuppressive drug at study entry for any reason other than kidney transplantation. 12. Subject or donor is known to be HIV positive. 13. Subject with malignancy or history of malignancy in the past five years, except non-metastatic basal or squamous cell carcinoma of the skin that has been treated successfully. 14. Subject has significant, uncontrolled concomitant infections or any other unstable medical condition that could interfere with the study objectives. 15. Subject is participating or has participated in another clinical trial and/or is taking or has taken an investigational drug in the past 28 days. 16. Subject is unlikely to comply with the visit schedule in the protocol. 17. Subject has any form of substance abuse, psychiatric disorder or condition that, in the opinion of the investigator may invalidate communication with the investigator.
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E.5 End points |
E.5.1 | Primary end point(s) |
Incidence (Kaplan-Meier estimate) of biopsy-confirmed acute rejection (Banff Grade ≥ 1) as assessed by local reading at month 6 (cumulative event rate) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 30 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |