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

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT00306397
First received: March 22, 2006
Last updated: June 29, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Kidney Transplantation
Drug: Rapamycin
Phase 4

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

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • Allograft function [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patients successfully withdrawn from calcineurin inhibitor after three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Graft survival [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
Rapamycin - MMF after 3 months
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 -
Other Names:
  • Sirolimus
  • Rapammune
Active Comparator: B
Low dose tacrolimus - MMF - Rapamycin after 3 months
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 -
Other Names:
  • Sirolimus
  • Rapammune

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00306397

Locations
Switzerland
University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Juerg U Steiger, MD University Hospital Basel, Clinic for Transplantation Immunology and Nephrology
  More Information

No publications provided

Responsible Party: Steiger Juerg / Professor, University Hospital Basel, Clinic for transplantation immunology and nephrology
ClinicalTrials.gov Identifier: NCT00306397     History of Changes
Other Study ID Numbers: CERL-080-CH02, 2004DR3379
Study First Received: March 22, 2006
Last Updated: June 29, 2010
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
Kidney transplantation
Steroid free
Calcineurin inhibitor free
Tacrolimus
Sirolimus

Additional relevant MeSH terms:
Immunosuppressive Agents
Sirolimus
Everolimus
Tacrolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antifungal Agents
Anti-Infective Agents
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on April 16, 2014