Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation (NCT02083991) | Clinical Trial Compass
CompletedPhase 4
Trial of Steroid Avoidance and Low-dose CNI by ATG-induction in Renal Transplantation
Sweden224 participantsStarted 2013-01
Plain-language summary
Balancing immunosuppressive treatment in organ transplantation in order to achieve effective prevention of rejection on one side and avoidance of negative side effects on the other side is a major challenge, leading to developing different immunosuppressive protocols. Cornerstones of immunosuppressive treatment such as Corticosteroids (CS) and Calcineurin Inhibitors (CNI) are known to cause an increased incidence of diabetes, cardiovascular morbidity, nephrotoxicity and malignancies.
The investigators believe that both avoidance of CS and minimization of CNI, while using Anti-ThymocyteGlobuline(ATG) induction (instead of interleucin-2 receptor blockers) and mycofenolate mofetil(MMF) therapeutic drug monitoring is going to reduce negative side effects, without increased rejection frequency in renal transplanted patients.
Who can participate
Age range
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:
* First or second single kidney (cadaveric or living donors) transplant recipients.
* Considered for a standard immunosuppressive protocol.
* Must be capable of giving written informed connect for participation in the study for 24 months.
Exclusion Criteria:
* Diabetes mellitus or plasma glucose \>11,1 at admission.
* Receiving steroids at the time of transplantation or likely to need steroids after transplantation.
* Multiorgan transplants and/or previously transplanted with any other organ than kidney.
* Panel reacting antibodies(PRA) \>25% in most recent test or considered to be of high risk for rejection which requires an enhanced immunosuppression.
* Renal transplants from HLA-identical sibling.
* Hypersensitivity to, or disability to take immunosuppressive drugs.
* Blood group(ABO)-incompatible transplants.
* Unlikely to comply with the study requirements.
* Transplant from donor positive for HIV, HBsAg, Hepatitis C.
* Female of childbearing potential planing/being pregnant or unwilling to use contraception.
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
1
Cumulative incidence of New Onset of Diabetes After Transplantation(NODAT)