NCT00693576

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 9, 2008

Completed
Last Updated

June 9, 2008

Status Verified

June 1, 2008

Enrollment Period

1.1 years

First QC Date

June 5, 2008

Last Update Submit

June 5, 2008

Conditions

Renal Transplantation

Keywords

renal transplantpanel reactive antibodysensitizationsimvastatinimmunological

Outcome Measures

Primary Outcomes (1)

  • effect of simvastatin on panel reactive antibody

    12 months

Study Arms (1)

A

EXPERIMENTAL

patients who will take simvastatin 20 mg daily

Drug: simvastatin

Interventions

simvastatinDRUG

20 mg simvastatin daily

A

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients with ESRD on hemodialysis or peritoneal dialysis
  • On the waiting list for renal transplant
  • PRA more than 25%

You may not qualify if:

  • Pregnant women
  • Patients who need ongoing blood products
  • Patients taking other therapies to decrease PRA
  • Patients listed for multi-organ transplant other than kidney
  • Patients with liver failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shiraz University of Medical Sciences

Shiraz, Fars, 71937-11351, Iran

Location

MeSH Terms

Interventions

Simvastatin

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • jamshid roozbeh, associate professor

    shiraz university of medical science

    STUDY DIRECTOR

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 5, 2008

First Posted

June 9, 2008

Study Start

April 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

June 9, 2008

Record last verified: 2008-06

Locations

IR(1)