E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
prophylaxis of acute rejection after renal transplantation |
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MedDRA Classification |
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 |
To determine the incidence and severity of biopsy-confirmed acute rejection within the first six months after transplantation. |
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E.2.2 | Secondary objectives of the trial |
To analyze: -Renal function as estimated by the endogenous creatinine clearance at 6 months -Occurrence of chronic allograft nephropathy at 6 months -Cumulative incidence of infections and malignancies at 6 months -Medical costs during the first 6 months after transplantation -Patient and graft survival
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. All renal transplant recipients older than 18 years 2. All female patients at risk for pregnancy must have a negative serum pregnancy test before randomization. Female patients at risk for pregnancy must agree to use a medically acceptable method of contraception throughout the treatment period and for 12 weeks after discontinuation of study medication. 3. Signed, dated, and witnessed institutional review board (IRB) approved informed consent before screening and before any tests are performed that are specific to the protocol.
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E.4 | Principal exclusion criteria |
1. Recipients of a kidney from a living donor, who is HLA identical. 2. Patients with hemolytic uremic syndrome as original kidney disease. 3. Patients with focal segmental glomerulosclerosis that had recurred in a previous graft 4. Recipients with more than two previously failed grafts and/or PRA > 85% 5. Previous treatment with anti-CD20 antibodies. 6. Diabetes mellitus that is currently not treated with insulin 7. Total white blood cell count <3,000/mm3 or platelet count <75,000/mm3. 8. Active infection with hepatitis B, hepatitis C, or HIV. 9. History of tuberculosis.
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E.5 End points |
E.5.1 | Primary end point(s) |
The incidence and severity of biopsy-confirmed acute rejections within the first six months after transplantation. |
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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 | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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 | Yes |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | Information not present in EudraCT |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Information not present in EudraCT |
E.7.4 | Therapeutic use (Phase IV) | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | Information not present in EudraCT |
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 | Information not present in EudraCT |
E.8.5 | The trial involves multiple Member States | No |
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 | No |
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 | 4 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |