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: Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: May 2008

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

Primary Measures

• effect of simvastatin on panel reactive antibody
  • Time Frame: 12 months
    Safety Issue?: Yes

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

Lead Sponsor: Shiraz University of Medical Sciences

Overall Clinical Trial Officials and Contacts

jamshid roozbeh, associate professor Study Director shiraz university of medical science  

Information obtained from ClinicalTrials.gov on July 02, 2009

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