Status:
TERMINATED
Lowering Total Immunosuppressive Load in Renal Transplant Recipients More Than 12 Months Posttransplant
Lead Sponsor:
University of Oslo School of Pharmacy
Conditions:
Renal Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy
Detailed Description
To compare the change in renal function between CsA or MMF withdrawal from before to 12 months after drug withdrawal in renal transplant recipients on triple immunosuppressive therapy. Secondly to ex...
Eligibility Criteria
Inclusion
- 1\. Patients of either gender above 18 years of age at time of randomisation. 2. More than twelve months posttransplant. 3. Treated with an immunosuppressive protocol consisting of CsA, MMF and steroid from the time of discharge from the transplant clinic (e.g. 3 months posttransplant).
- 4\. Kidney (only) transplant recipients with stable renal function (S-creatinine \< 300 umol/L and an average increase in S-creatinine \< 20% the last 6 months prior to inclusion) and without treated clinically and/or biopsy proven acute rejection episodes the last 6 months prior to inclusion.
- 5\. No previous steroid resistant acute rejections (e.g. treated with ATG/OKT3). 6. Not more than two steroid sensitive acute rejections posttransplant. 7. Signed informed consent.
Exclusion
- \- 1. PRA positivity \> 20%. 2. Concomitant therapy with other investigational drugs or prohibited medication specified in the protocol.
- 3\. Life expectancy less than one year. 4. Acute illness or acute fungal, bacterial or viral infection at screening. 5. Unable and/or unlikely to follow the study protocol.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
February 1 2007
Estimated Enrollment :
298 Patients enrolled
Trial Details
Trial ID
NCT00148252
Start Date
February 1 2003
End Date
February 1 2007
Last Update
June 7 2012
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Rikshospitalet, Section of Nephrology
Oslo, Oslo County, Norway, 0027
2
Haukeland sykehus
Bergen, Norway, 5021
3
Lillehammer hospital
Lillehammer, Norway, 2609
4
Akershus Hospital
Nordbyhagen, Norway, 1474