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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00693576
Enrollment
82
Registered
2008-06-09
Start date
2007-04-30
Completion date
2008-05-31
Last updated
2008-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Transplantation

Keywords

renal transplant, panel reactive antibody, sensitization, simvastatin, immunological

Brief 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.

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 .

Interventions

DRUGsimvastatin

20 mg simvastatin daily

Sponsors

Shiraz University of Medical Sciences
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

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

Design outcomes

Primary

MeasureTime frame
effect of simvastatin on panel reactive antibody12 months

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026