DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017