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.

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Key information

Conditions

Renal Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Shiraz University of Medical Sciences

Shiraz, Fars, 71937-11351, Iran

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

simvastatin

Drug

20 mg simvastatin daily

Primary outcomes

effect of simvastatin on panel reactive antibody

Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Shiraz University of Medical Sciences

Other

Registry information

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jun 9, 2008
Registry last updated: Jun 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed