Status:
TERMINATED
Tacrolimus to Sirolimus Conversion for Delayed Graft Function
Lead Sponsor:
University of Maryland, Baltimore
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Kidney Transplant
Delayed Graft Function
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The objective of this study is to evaluate the safety and efficacy of conversion from tacrolimus to sirolimus early after kidney transplantation in patients with delayed graft function (DGF)and slow g...
Detailed Description
Eligible study subjects will be randomized into two groups 8-18 weeks after surgery. One group will be maintained on tacrolimus according to the standard of care at our center. In the second group tac...
Eligibility Criteria
Inclusion
- Age =\> 18.
- Recipient of a deceased donor kidney transplant.
- Delayed graft function, defined as need for dialysis during first week after surgery or slow graft function, defined as creatinine \>=3.0 by post-op day 5 without requiring dialysis
- Stable serum creatinine for 2 weeks prior to enrollment.
- Able to give informed consent.
- Compliant with medical regimen and clinic visits.
Exclusion
- Episode of acute rejection within 4 weeks prior to enrollment.
- Calculated GFR \< 30 ml/min.
- Interstitial fibrosis \& tubular atrophy in transplant biopsy higher than grade II (Banff"05 update).
- Proteinuria \> 500 mg/24 h or spot urine protein/creatinine \> 0.5.
- Total fasting cholesterol level \> 300 mg/dl or triglyceride \> 500 mg/dl despite optimal lipid lowering therapy.
- Recipient of pancreas or liver allografts.
- Leukopenia (WBC \< 3000 mm3) within 2 weeks prior to enrollment.
- Leukopenia (WBC \< 2000 mm3) within 4 weeks prior to enrollment.
- Thrombocytopenia (platelets count \< 100,000/mm3) within 2 weeks prior to enrollment.
- Unwilling to comply with study protocol.
- Enrollment in another drug trial that precludes use of sirolimus.
- Diagnosis of malignancy within 2 years prior to enrollment, except adequately treated non-melanoma skin cancer.
- For women, pregnancy.
- Allergy to iodine
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT00931255
Start Date
April 1 2009
End Date
July 1 2014
Last Update
March 31 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Maryland Medical Center
Baltimore, Maryland, United States, 21201