Tacrolimus to Sirolimus Conversion for Delayed Graft Function (NCT00931255) | Clinical Trial Compass
TerminatedPhase 4
Tacrolimus to Sirolimus Conversion for Delayed Graft Function
Stopped: The trial was stopped because of slow recruitment.
United States32 participantsStarted 2009-04
Plain-language 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 graft function (SGF) in improving graft function and delaying chronic allograft nephropathy. The investigators hypothesize that conversion from tacrolimus to sirolimus in renal transplant recipients with DGF/SGF in early months after surgery will improve graft function and decrease the progression of graft fibrosis.
Who can participate
Age range18 Years – 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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 criteria
✕. 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.
What they're measuring
1
The Composite Endpoint of Reduction of e eGFR at One Year by More Than 15% & the Progression in Fibrosis Score at One Year by >=20% Compared With the Baseline Values