An Open, Single Centre, Randomised, Parallel Group Study to Investigate Three Different Immunosuppressive Regimens

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

An open, single center, randomised study to investigate three different immunosuppressive regimens for de novo renal transplant recipients:

1. st sirolimus / EC-MPS / tacrolimus regimen

• After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.

2. nd everolimus / EC-MPS / tacrolimus regimen

• After 3 months a protocol biopsy is performed. If no rejection is detected the calcineurin inhibitor (tacrolimus) is withdrawn.

3. rd tacrolimus / EC-MPS / prednisone regimen - After 3 months a protocol biopsy is performed. If no rejection is detected prednisone is withdrawn.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Basel, Switzerland
• Collaborator: Novartis
• Treatments: Everolimus; Immunosuppressive Agents; Prednisone; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

1. Male or female patients between 18 and 75 years of age, regardless of race.

2. Female patients of child bearing age agree to maintain effective birth control practice during the study.

3. Patient has end stage kidney disease and is a suitable candidate for primary renal transplantation or retransplantation as assessed by the transplantation centre.

4. Patient has been fully informed and has given written or independent person witnessed oral informed consent.

Exclusion Criteria:

1. in Patient is pregnant or breastfeeding.

2. Patient has a low immunological risk constellation, defined by receiving a kidney from a HLA-identical related living donor.

3. Patient has a high immunological risk constellation, defined as having donor specific HLA-antibodies and/or having a previous graft survival shorter than 3 years due to rejection.

4. Patient and donor have a positive T or B-cell crossmatch.

5. Patient and donor are ABO incompatible.

6. Age of donor > 75 years.

7. Cold ischemia time > 36 hours.

8. Patient has leucopenia, defined as having at transplantation less than 3000/mm3 leukocytes.

9. Patient has thrombocytopenia, defined as having at transplantation less than 75000/mm3 thrombocytes.

10. Patient is allergic or intolerant to cremophor RH 60 or structurally related compounds, steroids, everolimus, tacrolimus, Sirolimus or EC-MPS.

11. Patient or donor is known to be HIV positive.

12. Patient has significant liver disease, defined as having during the past 28 days continuously ASAT (SGOT) and/or ALAT (SGPT) levels greater than 3 fold of the upper value of the normal range of the investigational site.

13. Patient with malignancy or history of malignancy ≤ 2 years, except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.

14. Patient has significant, uncontrolled concomitant infections and/or severe diarrhea, vomiting, or active peptic ulcer.

15. Patient is taking or has been taking an investigational drug in the past 28 days.

16. Patient has previously received or is receiving another organ transplant other than kidney.

17. Patient is unlikely to comply with the visits schedule the protocol.