The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- effect of simvastatin on panel reactive antibody
Study Overview
Brief Summary
Patients with panel reactive antibodies have many difficulties to find a crossmatch-negative kidney for transplantation and are at the risk of post transplantation rejection more than other transplanted patients. We evaluated the effect of simvastatin on PRA and post transplant outcome of these sensitized patients. We also performed a descriptive study.
Detailed Description
The presence of panel reactive antibodies (PRAs) in the sera of renal transplant candidates is associated with hyperacute or delayed humoral immune responses against the graft after transplantation .
In addition, these sensitized patients wait for a long time to find a cross-match negative kidney for renal transplantation . As a result, some modalities have been used for desensitization including plasmapheresis and intravenous immunoglobulin (IVIG) in combination with immunosuppressive drugs .
However, recently, the use of statins such as simvastatin, pravastatin and etc. has been proposed to be safer and more effective for desensitization .
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •patients with ESRD on hemodialysis or peritoneal dialysis
- •On the waiting list for renal transplant
- •PRA more than 25%
Exclusion Criteria
- •Pregnant women
- •Patients who need ongoing blood products
- •Patients taking other therapies to decrease PRA
- •Patients listed for multi-organ transplant other than kidney
- •Patients with liver failure
Arms & Interventions
A
patients who will take simvastatin 20 mg daily
Intervention: simvastatin (Drug)
Outcomes
Primary Outcomes
effect of simvastatin on panel reactive antibody
Time Frame: 12 months
Secondary Outcomes
No secondary outcomes reported