Effect of Rapid Steroid Withdrawal on Subclinical Markers of Rejection

Evaluation of the Long-term Safety and Efficacy of a Tacrolimus-based 5-day Steroid Rapid Withdrawal Immunoprophylactic Regimen in de Novo Renal Transplantation

Status

Terminated

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00133172

Enrollment

Registered

2005-08-23

Start date

2005-07-31

Completion date

2007-03-31

Last updated

2014-09-08

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

Conditions

Kidney Transplantation

Keywords

Treatment Efficacy, Treatment Effectiveness, Anti-rejection therapy, Immunosuppression, Antirejection, Renal Transplantation, Transplantation, Renal, Transplantation, Kidney, Grafting, Kidney

Brief summary

The purpose of this study is to compare the safety and efficacy of a tacrolimus-based 5-day steroid rapid withdrawal immunoprophylactic regimen in de novo renal transplantation.

Interventions

DRUGTacrolimus

DRUGmycophenolate mofetil

DRUGPrednisone

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject or legally acceptable guardian has signed and dated a Research Ethics Board (REB)-approved informed consent form and is willing and able to follow study procedures. * Subject is the recipient of a first or second cadaveric or living donor mismatched (at least one mismatch) renal transplant. * Subject is 18 years of age or over at the time of transplant. * If female and of child-bearing potential, subject has a negative pregnancy test and utilizes adequate contraceptive methods

Exclusion criteria

* Recipients of a kidney from a donor 60 years of age or older * Recipients of donation after cardiac death (DCD) donors * Recipients of a combined transplant (e.g. kidney-pancreas, -lung, -heart) * Subjects with a second renal allograft who had their original graft for \< 2 years, unless the initial graft was lost in the early (1 year or less) post transplant course due to a technical or surgical failure * Subjects with a current/latest pre-transplant panel of reactive antibodies (PRA) \>20 * Subjects with hepatitis B & C, HIV or cancer (excluding successfully excised squamous or basal cell carcinoma) * Subjects receiving an allograft with cold ischemia time 24 hours or greater * Subjects who have received an investigational drug within three months prior to randomization * Subjects who are breastfeeding * Subjects with known hypersensitivity to tacrolimus, mycophenolate mofetil, methylprednisolone, basiliximab, prednisone, or any related drugs or their excipients * Subjects with significant disease (e.g. uncontrolled infection) or disability (e.g. cognitive deficit) that prevents understanding of or adherence to the protocol

Design outcomes

Primary

Measure	Time frame
Combined incidence of biopsy proven subclinical rejection (BPSCR) and biopsy proven clinical acute rejection (BPCAR)	3 months post transplant

Secondary

Measure	Time frame
Biopsy proven chronic allograft nephropathy(CAN)	2 years post transplant
Patient and graft survival rates	End of study (5 years)

Countries

Canada

Outcome results

None listed

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