Recruiting

Tacrolimus & Sirolimus

Sponsor:

Temple University

Code:

NCT00999258

Conditions

Glomerular Filtration Rate

Chronic Allograft Nephropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sirolimus

Study Details

Brief summary:

The objective of this study is to examine the effect on allograft function and histology of converting African American renal transplant recipients with chronic allograft nephropathy (CAN) from a tacrolimus-based regimen to a sirolimus-based maintenance immunosuppression regimen.

The investigators hypothesize that the conversion from tacrolimus to sirolimus in African American renal recipients will stabilize or improve renal allograft function, and stabilize the histological progression of CAN. This conversion will have the potential to prolong long-term graft survival in African American renal transplant patients.

GFR measurements, histological parameters on the allograft biopsy, as well as patient and graft survival, incidence of acute rejection, and specific side effects will be monitored and compared between the sirolimus conversion group and the patients who will be maintained on tacrolimus.

Conditions

Glomerular Filtration Rate

Chronic Allograft Nephropathy

Study ID

NCT00999258

Start date

Sep, 2009

Status verified date

Oct, 2009

Completion date

Jun, 2011

Anticipated

Primary completion date

Jun, 2011

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • African American (self-identified) renal transplant recipients.
  • Primary or re-transplant kidney-only recipients.
  • Recipients on tacrolimus-based immunosuppression regimen.
  • Time interval after transplant: at least 3 months but not greater than 5 years.
  • Renal transplant recipients with 10% decrease in GFR from baseline.
  • Women of childbearing potential must have a negative pregnancy test upon enrollment, and must consent to receive contraceptive counseling and to use effective contraception while enrolled in the study. Two reliable forms of contraception must be used simultaneously unless abstinence is the chosen method.

Exclusion Criteria:

  • GFR <40ml/min.
  • Urine protein-to-creatinine ratio >0.5.
  • Significant chronic allograft nephropathy grade 3 Banff score.
  • Evidence of acute rejection episodes within the past 3 months.
  • Evidence of active infection within the past month.
  • Any malignancy except treated non-melanoma skin cancer within the past 3 years.
  • Leucopenia <2,000/mm3 within the past month.
  • Thrombocytopenia <100,000/mm3 within the past month.
  • Total cholesterol >300mg/dl, despite adequate treatment.
  • Triglycerides >500mg/dl, despite adequate treatment.
  • Non-healed post-surgical or non-surgical wound.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: sirolimus

the subjects will undergo conversion from tacrolimus to sirolimus OR they will continue to receive tacrolimus.

no intervention: tacrolimus

Interventions

sirolimus

The subjects assigned to the sirolimus conversion group will be initiated on sirolimus 5mg po daily at which time their tacrolimus dose will be decreased by 50%. Sirolimus levels will be checked within a week and adjusted in a linear fashion to achieve a trough goal of 12-15ng/ml in subjects within 1 year post-transplant, and 8-12 ng/ml in subjects more than 1 year post-transplant. Tacrolimus will be continued in these subjects until sirolimus target trough levels are achieved. Thereafter, tacrolimus will be discontinued indefinitely.

The subjects assigned to the tacrolimus maintenance group (control group) represent our present standard of care.

Primary outcome measure

  • Glomerular filtration rate measured by Gd-DTPA [ Time Frame: 6 months, and 1 year ]

Central Contacts and Locations

Central contacts

Serban Constantinescu, MD, PhD

215-707-9171serban.constantinescu@tuhs.temple.edu

Sandra Amoroso, RN

215-707-7935sandra.amoroso@tuhs.temple.edu

Locations

Temple University

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Serban Constantinescu, MD, PhD

217-707-9171serban.constantinescu@tuhs.temple.edu

Principal Investigator:

Serban Constantinescu, MD, PhD

More Information

Sponsor

Temple University

Last update posted

Oct 21, 2009

Last verified

Oct, 2009

Keywords

  • glomerular filtration rate
  • chronic allograft nephropathy
  • Kidney transplantation
  • African American

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Temple University on 2009-10-21.