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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00693576
First Posted: June 9, 2008
Last Update Posted: June 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shiraz University of Medical Sciences
  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 2 Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of Simvastatin on Desensitization of Panel-Positive Kidney Transplant Candidates

Resource links provided by NLM:


Further study details as provided by Shiraz University of Medical Sciences:

Primary Outcome Measures:
  • effect of simvastatin on panel reactive antibody [ Time Frame: 12 months ]

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
Experimental: A
patients who will take simvastatin 20 mg daily
Drug: simvastatin
20 mg simvastatin daily

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

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00693576


Locations
Iran, Islamic Republic of
Shiraz University of Medical Sciences
Shiraz, Fars, Iran, Islamic Republic of, 71937-11351
Sponsors and Collaborators
Shiraz University of Medical Sciences
Investigators
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
ClinicalTrials.gov Identifier: NCT00693576     History of Changes
Other Study ID Numbers: 2519
First Submitted: June 5, 2008
First Posted: June 9, 2008
Last Update Posted: June 9, 2008
Last Verified: June 2008

Keywords provided by Shiraz University of Medical Sciences:
renal transplant
panel reactive antibody
sensitization
simvastatin
immunological

Additional relevant MeSH terms:
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors