The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
Information source: Shiraz University of Medical Sciences
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Renal Transplantation
Intervention: simvastatin (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Shiraz University of Medical Sciences Official(s) and/or principal investigator(s): jamshid roozbeh, associate professor, Study Director, Affiliation: shiraz university of medical science azar Sattarinezhad, internal medicine resident, Principal Investigator, Affiliation: shiraz university of medical science,internal medicine department mohammad mahdi sagheb, assistant professor, Principal Investigator, Affiliation: Shiraz University of Medical Sciences
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.
Clinical Details
Official title: The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: effect of simvastatin on panel reactive antibody
Detailed 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 .
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Shiraz University of Medical Sciences, Shiraz, Fars 71937-11351, Iran, Islamic Republic of
Additional Information
Starting date: April 2007
Last updated: June 5, 2008
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