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

Kidney Transplantation Clinical Trial

Official title:

Open, Single Centre, Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for De Novo Renal Transplant Recipients Followed by Randomisation to Calcineurin Inhibitor Containing or Calcineurin Inhibitor Free Immunosuppression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00306397
• Other study ID #: CERL-080-CH02
• Secondary ID: 2004DR3379
• Status: Completed
• Phase: Phase 4
• First received: March 22, 2006
• Last updated: June 29, 2010
• Start date: January 2005
• Est. completion date: December 2008

Study information

• Verified date: June 2010
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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• Patients successfully withdrawn from calcineurin inhibitor at three months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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Kidney Transplantation

Intervention

Drug:
• Rapamycin
Sirolimus perorally following kidney transplantation, randomisation after protocol biopsy at months three to a) Sirolimus - MF- or b) low dose tacrolimus - sirolimus -MMF -

Locations

Country	Name	City	State
Switzerland	University Hospital Basel, Clinic for Transplantation Immunology and Nephrology	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allograft function		6 months	No
Secondary	Patients successfully withdrawn from calcineurin inhibitor after three months		3 months	No
Secondary	Graft survival		6 months	No
Secondary	Patient survival		6 months	Yes