TerminatedPhase 1/2

Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

Stopped: Enrollment suspended pending protocol revision to change study to observational

United States33 participantsStarted 2004-06

Plain-language summary

The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.

Who can participate

Age range

18 Months – 18 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: * Participants must be a single-organ recipient (kidney only) * Participants who are receiving their first living donor or deceased donor transplant Exclusion Criteria: * Participants who are recipients of HLA-identical living-donor renal transplants * Participants with a PRA value \> 10% within 30 days prior to the transplant * Participants who have received a multi-organ transplant * Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV * Participants who have received an investigational drug within 6 weeks of study entry * Participants who have a previous history of, or who currently have, malignancies and/or lymphoma * Participants who have received corticosteroids within three months of transplantation * Participants who are 3rd transplant recipients * Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study

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

Incidence of Graft Rejection

Timeframe: at 1, 3, 6, 12, and 24 months

Participant Graft Survival

Timeframe: at 6, 12, and 24 months

Trial details

NCT IDNCT00167661

SponsorUniversity of Wisconsin, Madison

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-12

Results submitted2020-08-31

View on ClinicalTrials.gov More Disorder Related to Renal Transplantation trials

Who can participate

Age range

18 Months – 18 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.