Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients

University Hospital Basel

Status and phase

Completed

Phase 4

Conditions

Kidney Transplantation

Treatments

Drug: Rapamycin

Study type

Interventional

Funder types

Other

Identifiers

NCT00306397

CERL-080-CH02

2004DR3379

Details and patient eligibility

About

The main purpose of this study is to investigate, whether a steroid free immunosuppressive treatment is a valuable alternative in the treatment of de novo kidney transplant recipients and if it is possible to withdraw calcineurin inhibitors after 3 months.

Full description

Protocol synopsis Title An open, single centre, pilot study to investigate a steroid free immunosuppressive regimen for de novo renal transplant recipients followed by a two arm randomization to a calcineurin inhibitor containing and a calcineurin inhibitor free maintenance immunosuppression after three months. Study code Sterfree pilot study Project phase An open, single centre, one arm study followed by a 1:1 randomized, parallel group, comparative study after three months. Study objectives To obtain preliminary information on the efficacy and safety of a rapamycin / sodium-mycophenolate (Myfortic) / tacrolimus regimen in the absence of steroids for the prevention of acute rejection following renal transplantation. To compare a low dose tacrolimus / rapamycin / sodium-mycophenolate (Myfortic) regimen to a rapamycin / sodium-mycophenolate regimen in patients without evidence of acute rejection after three months.

Efficacy:

Primary endpoint

Plasma creatinine (and creatinine clearance (Cockcroft)) Secondary endpoints
Incidence of first acute rejections and total number of acute rejections
Total number of anti-rejection treatments
Patients successfully withdrawn from calcineurin inhibitor at three months
Graft survival
Patient survival

Safety:

Graft survival
Patient survival
Protocol biopsies at 3 months( range: day 75 to 105) and 6 months (range day 165 to 195) sub clinical rejection
Incidence of first acute biopsy proven rejection and total number of acute rejection episodes
Total number of anti-rejection treatments
Patients switched from assigned therapy due to rejection or side effects
Patients needing steroids because of rejection
Incidence of selected adverse events: tubulointerstitial nephrotoxicity (TOR inhibitor), leucopenia, thrombocytopenia, elevated fasting blood glucose, dyslipidemia, , electrolyte disturbances, de novo insulin dependency, gastrointestinal disorders (non infectious), neurotoxicity.
Patients withdrawn due to adverse events

Long term patient follow up Patients will be followed up for graft and patient survival at 12, 24, and 36 months post-transplantation.

Enrollment

100 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

adult patients with end stage kidney disease suitable for primary renal transplantation or retransplantation
patients receiving a graft from a living related, living unrelated or brain-death donor

Exclusion criteria