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CompletedNCT00693576Updated Jun 9, 2008

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

A Phase 2/3 interventional study of simvastatin in Renal Transplantation, sponsored by Shiraz University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-06-09.

Sponsored by Shiraz University of Medical Sciences · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
82
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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 .

02

Conditions studied

  • Renal Transplantation

Keywords

  • renal transplant
  • panel reactive antibody
  • sensitization
  • simvastatin
  • immunological
03

In context

Lead sponsor

Shiraz University of Medical Sciences is the lead sponsor of 129 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
82 participants (actual)

Study arms

  • Experimental
    A

    patients who will take simvastatin 20 mg daily

    Drug: simvastatin

Interventions

  • Drugsimvastatin

    20 mg simvastatin daily

06

What researchers measure

Primary outcomes

  1. effect of simvastatin on panel reactive antibody

    Time frame: 12 months

07

Study locations

1 site
  • Shiraz University of Medical Sciences
    Shiraz, Fars 71937-11351, Iran, Islamic Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00693576
Lead sponsor
Shiraz University of Medical Sciences
First posted
Jun 9, 2008
Start date
Apr 2007
Primary completion
May 2008
Completion
May 2008
Last update
Jun 9, 2008

Study contacts

jamshid roozbeh, associate professor
study director · shiraz university of medical science
azar Sattarinezhad, internal medicine resident
principal investigator · shiraz university of medical science,internal medicine department
mohammad mahdi sagheb, assistant professor
principal investigator · Shiraz University of Medical Sciences

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2008. You cannot join it, but the record below documents what was studied.

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