Pilot Study to Investigate a Steroid Free Immunosuppressive Regimen for Renal Transplant Recipients
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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 |
- Allograft function [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Patients successfully withdrawn from calcineurin inhibitor after three months [ Time Frame: 3 months ] [ Designated as safety issue: No ]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:
|
|
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:
|
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 |
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| Switzerland | |
| University Hospital Basel, Clinic for Transplantation Immunology and Nephrology | |
| Basel, Switzerland, 4031 | |
| 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 May 19, 2013