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

NCT ID: NCT00693576

Last Updated: 2008-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2008-05-31

Brief Summary

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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.

Detailed Description

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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 .

Conditions

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Renal Transplantation

Keywords

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renal transplant panel reactive antibody sensitization simvastatin immunological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

patients who will take simvastatin 20 mg daily

Group Type EXPERIMENTAL

simvastatin

Intervention Type DRUG

20 mg simvastatin daily

Interventions

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simvastatin

20 mg simvastatin daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Shiraz university of medical science

Principal Investigators

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jamshid roozbeh, associate professor

Role: STUDY_DIRECTOR

shiraz university of medical science

azar Sattarinezhad, internal medicine resident

Role: PRINCIPAL_INVESTIGATOR

shiraz university of medical science,internal medicine department

mohammad mahdi sagheb, assistant professor

Role: PRINCIPAL_INVESTIGATOR

Shiraz University of Medical Sciences

Locations

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Shiraz University of Medical Sciences

Shiraz, Fars, Iran

Site Status

Countries

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Iran

Other Identifiers

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2519

Identifier Type: -

Identifier Source: org_study_id