NCT00999258

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 21, 2009

Status Verified

October 1, 2009

Enrollment Period

1.7 years

First QC Date

October 20, 2009

Last Update Submit

October 20, 2009

Conditions

Glomerular Filtration RateChronic Allograft Nephropathy

Keywords

glomerular filtration ratechronic allograft nephropathyKidney transplantationAfrican American

Outcome Measures

Primary Outcomes (1)

  • Glomerular filtration rate measured by Gd-DTPA

    6 months, and 1 year

Secondary Outcomes (2)

  • Quantification the histological markers on renal allograft biopsy

    1 year

  • Patient survival, graft survival, and incidence of acute rejection

    1 year

Study Arms (2)

sirolimus

ACTIVE COMPARATOR

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

Drug: sirolimus

tacrolimus

NO INTERVENTION
Drug: sirolimus

Interventions

sirolimusDRUG

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.

Also known as: GFR measurements and allograft biopsies
sirolimustacrolimus

Eligibility Criteria

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Temple University

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

MeSH Terms

Interventions

Sirolimus

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Serban Constantinescu, MD, PhD

    Temple University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Serban Constantinescu, MD, PhD

CONTACT

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

Sandra Amoroso, RN

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2009

First Posted

October 21, 2009

Study Start

September 1, 2009

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 21, 2009

Record last verified: 2009-10

Locations

US(1)