NCT00214279

Brief Summary

Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2002

Longer than P75 for not_applicable

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

May 1, 2002

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 14, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
Last Updated

June 26, 2012

Status Verified

June 1, 2012

Enrollment Period

5.5 years

First QC Date

September 14, 2005

Last Update Submit

June 22, 2012

Conditions

Renal Transplantation

Outcome Measures

Primary Outcomes (1)

  • Incidence of Allograft rejection

    3 years

Secondary Outcomes (3)

  • Renal function as determined by serum creatinine

    measure after 36 months

  • Allograft Survival

    3 years

  • Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)

    Day 0 (pre-transplant)

Study Arms (2)

1

NO INTERVENTION

Remain on 3-drug standard of care immunosuppression including prednisone

2

EXPERIMENTAL

Corticosteroid withdrawal / prednisone taper over 14 weeks

Drug: Corticosteroid withdrawal

Interventions

Corticosteroid withdrawalDRUG

prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

2

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient who have received a kidney transplant during the "MMF era"
  • Patients who have stable graft function indicated by a serum creatinine of \< 1.8 mg/dl, or a calculated creatinine clearance of \> 50 ml/minute

You may not qualify if:

  • Patients who have had \> 1 rejection episode,
  • Patients who have had a rejection episode within the past year;
  • Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unversity of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Study Officials

  • Hans Sollinger, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2005

First Posted

September 21, 2005

Study Start

May 1, 2002

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

June 26, 2012

Record last verified: 2012-06

Locations

US(1)