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

This study has been completed.
Sponsor:
Information provided by:
Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT00693576
First received: June 5, 2008
Last updated: NA
Last verified: June 2008
History: No changes posted
  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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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
Other Name: simvastatin

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Shiraz university of medical science
ClinicalTrials.gov Identifier: NCT00693576     History of Changes
Other Study ID Numbers: 2519
Study First Received: June 5, 2008
Last Updated: June 5, 2008
Health Authority: Iran: Ethics Committee

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

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

ClinicalTrials.gov processed this record on October 23, 2014