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

Shiraz University of Medical Sciences

Status and phase: Completed; Phase 3; Phase 2

Conditions: Renal Transplantation

Treatments: Drug: simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00693576

2519

Details and patient eligibility

About

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.

Full 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 .

Enrollment: 82 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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82 participants in 1 patient group

A

Experimental group

Description:

patients who will take simvastatin 20 mg daily

Treatment:

Drug: simvastatin