TerminatedPhase 4

Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

Stopped: due to low study enrollment

United States18 participantsStarted 2005-10

Plain-language summary

The purpose of the study was to determine if rapid discontinuation of corticosteroids (also known as prednisone withdrawal) and maintenance immunosuppression with Prograf (tacrolimus) and CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin) will give similar safety and efficacy results compared to continuation of corticosteroids (also known as prednisone maintenance) and standard maintenance immunosuppression with Prograf (tacrolimus), CellCept (mycophenolate mofetil) while using Thymoglobulin (Rabbit antithymocyte globulin).

Who can participate

Age range

19 Years – 74 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * First time kidney transplant recipients who receives a kidney from a cadaveric, living related or living unrelated donor * Age greater than 18 years and less than 75 years * Caucasian recipients * Patients with current low panel reactive antibody (PRA) levels (\<10%) * Patients with signed and dated informed consent * Women of childbearing potential must have a negative pregnancy test at baseline and agree to use a medically acceptable method of contraception throughout the treatment period. Exclusion Criteria: * Other than Caucasian ethnicity * Patients with HIV+ or * Patients with HbsAg+ or Hepatitis C positive * Patients with a history of malignancy in the past 5 years * Patients with active systemic or localized major infection * Patients with a history of chronic steroid use for other diseases

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

The Number of Participants With Acute Rejection Episodes

Timeframe: 6 and 12 months post-transplant

The Number of Participants With Graft Survival

Timeframe: 6 and 12 months

Participant Survival

Timeframe: 6 and 12 months

Trial details

NCT IDNCT00596947

SponsorUniversity of Pennsylvania

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-03

Results submitted2011-02-18

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