Efficacy and Safety of Sirolimus in Combination With Tacrolimus

• Status: Unknown status
• Trial end date: 2005-06-01
• Target enrollment: 0
• Participant gender: All

Summary

To study the efficacy and safety of the administration of Tacrolimus in combination with Sirolimus for the prevention of acute rejection in patients after renal transplantation

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital Muenster
• Collaborators: Fujisawa GmbH; KKS Netzwerk; Proverum GmbH
• Treatments: Everolimus; Sirolimus; Tacrolimus

Criteria

Inclusion Criteria:

• first kidney transplantation

• re-transplantation

• non-related living donor transplantation

• patients > 18 years

• patients have given their written consent after being informed

• female patients in the age of parity must consent to an effective birth control and submit a negative pregnancy test

Exclusion Criteria:

• related living donation

• patients with known HIV-anamnesis

• patients who need systemically administered immunosuppression for another indication than the prophylaxis of kidney graft rejection

• patients with present malignant disease

• patients with clinically significant, uncontrolled infectional disease and/or severe diarrhea, vomiting or active gastric ulcer

• patients who haven taken part in a clinical study in the past 28 days and/or receive (received) medication which is not licensed by the responsible health authority

• other reasons which depend on the assessment of the physician