The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
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...
Brief Summary
Official Title: “The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates”
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.
- Study Type: Interventional
- Study Design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
- Study Primary Completion Date: May 2008
Detailed Clinical Trial 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 .
Intervention(s) in this Clinical Trial
- Drug: simvastatin
- 20 mg simvastatin daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: A
- patients who will take simvastatin 20 mg daily
Outcome Measures for this Clinical Trial
Primary Measures
- effect of simvastatin on panel reactive antibody
- Time Frame: 12 months
Safety Issue?: Yes
- Time Frame: 12 months
Criteria for Participation in this Clinical Trial
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
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 75 Years
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Shiraz University of Medical Sciences Other
Overall Clinical Trial Officials and Contacts
jamshid roozbeh, associate professor Study Director shiraz university of medical science
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00693576
Study ID Number: 2519
ClinicalTrials.gov Identifier: NCT00693576
Health Authority: Iran: Ethics Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00693576
