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

Renal Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00693576
• Other study ID #: 2519
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: June 5, 2008
• Last updated: June 5, 2008
• Start date: April 2007
• Est. completion date: May 2008

Study information

• Verified date: June 2008
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Transplantation

Intervention

Drug:
• simvastatin
20 mg simvastatin daily

Locations

Country	Name	City	State
Iran, Islamic Republic of	Shiraz University of Medical Sciences	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of simvastatin on panel reactive antibody		12 months	Yes