The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates

Phase 2

Completed

• Conditions: Renal Transplantation
• Interventions: Drug: simvastatin

• Registration Number: NCT00693576
• Lead Sponsor: Shiraz University of Medical Sciences

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 Timeline

• Study Start: 2007-04
• Primary Completion: 2008-05
• Study Completion: 2008-05
• Status Verified: 2008-06
• Study First Submitted: 2008-06-05
• Study First Submitted QC: 2008-06-05
• Last Update Submitted: 2008-06-05
• Study First Posted: 2008-06-09
• Last Update Posted: 2008-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. patients with ESRD on hemodialysis or peritoneal dialysis
2. On the waiting list for renal transplant
3. PRA more than 25%

Exclusion Criteria

1. Pregnant women
2. Patients who need ongoing blood products
3. Patients taking other therapies to decrease PRA
4. Patients listed for multi-organ transplant other than kidney
5. Patients with liver failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	simvastatin	patients who will take simvastatin 20 mg daily

Primary Outcome Measures

Name	Time	Method
effect of simvastatin on panel reactive antibody	12 months

Trial Locations

Locations (1)

Shiraz University of Medical Sciences; 🇮🇷 Shiraz, Fars, Iran, Islamic Republic of