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

Phase 4

Completed

• Conditions: Kidney Transplantation
• Interventions: Drug: Rapamycin

• Registration Number: NCT00306397
• Lead Sponsor: University Hospital, Basel, Switzerland

Brief Summary

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.

Detailed 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* Patients successfully withdrawn from calcineurin inhibitor at three months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.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-03-22
• Study First Submitted QC: 2006-03-22
• Study First Posted: 2006-03-23
• Primary Completion: 2008-06
• Study Completion: 2008-12
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

• patients with a low or high immunological risk constellation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Rapamycin	Rapamycin - MMF after 3 months
B	Rapamycin	Low dose tacrolimus - MMF - Rapamycin after 3 months

Primary Outcome Measures

Name	Time	Method
Allograft function	6 months

Secondary Outcome Measures

Name	Time	Method
Patients successfully withdrawn from calcineurin inhibitor after three months	3 months
Graft survival	6 months
Patient survival	6 months

Trial Locations

Locations (1)

University Hospital Basel, Clinic for Transplantation Immunology and Nephrology; 🇨🇭 Basel, Switzerland