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| Sponsored by: |
Shiraz University of Medical Sciences |
|---|---|
| Information provided by: | Shiraz University of Medical Sciences |
| ClinicalTrials.gov Identifier: | NCT00693576 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Transplantation |
Drug: simvastatin |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates |
| Enrollment: | 82 |
| Study Start Date: | April 2007 |
| Study Completion Date: | May 2008 |
| Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
A: Experimental
patients who will take simvastatin 20 mg daily
|
Drug: simvastatin
20 mg simvastatin daily
|
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Iran, Islamic Republic of, FARS | |
| Shiraz University of Medical Sciences | |
| SHIRAZ, FARS, Iran, Islamic Republic of, 71937-11351 | |
| Study Director: | jamshid roozbeh, associate professor | shiraz university of medical science |
| Principal Investigator: | azar Sattarinezhad, internal medicine resident | shiraz university of medical science,internal medicine department |
| Principal Investigator: | mohammad mahdi sagheb, assistant professor | Shiraz University of Medical Sciences |
More Information
| Responsible Party: | Shiraz university of medical science ( Shiraz university of medical science ) |
| Study ID Numbers: | 2519 |
| Study First Received: | June 5, 2008 |
| Last Updated: | June 5, 2008 |
| ClinicalTrials.gov Identifier: | NCT00693576 |
| Health Authority: | Iran: Ethics Committee |
|
renal transplant panel reactive antibody sensitization simvastatin immunological |
|
Antibodies Simvastatin Immunoglobulins |
|
Antimetabolites Molecular Mechanisms of Pharmacological Action Therapeutic Uses Antilipemic Agents |
Enzyme Inhibitors Anticholesteremic Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Pharmacologic Actions |
