CompletedPhase 1

MIC Cell Therapy for Individualized Immunosuppression in Living Donor Kidney Transplant Recipients

Germany14 participantsStarted 2015-08-05

Plain-language summary

A phase- I clinical trial to determine safety and feasibilty of intravenous administration of mitomycin C-treated donor peripheral blood mononuclear cells in patients with chronic kidney disease stage KDIGO 4 or 5 (i.e. GFR 15-30 mL/min or \< 15 mL/min) who receive a kidney transplant from a living donor.

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: * Chronic kidney disease stage KDIGO 4 or 5 * First kidney transplant from a living donor * Age ≥ 18 years * ABO compatible * CDC-PRA \< 20% * No donor-specific antibodies * Negative CDC and ELISA crossmatch * Immunosuppression with cyclosporin A, EC-MPS and methylprednisolone * Informed consent * Adequate contraception (women with child bearing potential) Exclusion Criteria: * Psychiatric disorder * Heart failure (NYHA III or IV) * Severe liver disease * Active hepatitis B or C or HIV infection * Active bacterial, fungal or viral disease * Malignancy or malignancy in the last 5 years before screening * Preexisting immunosuppression * Vaccination with a live vaccine in the last 3 months before screening * S/p splenectomy * Substance abuse * Pregnancy or lactation * Women: Child/pregnancy with the intended donor * Allergy against the investigational drug or part of it * Other diseases that prohibit participation in the study (in the opinion of the investigator) * Participation in an other interventional 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

The primary outcome measure is the frequency of adverse events after intravenous administration of MICs within 30 days after transplantation.

Timeframe: 30 days

Trial details

NCT IDNCT02560220

SponsorHeidelberg University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-04-18

View on ClinicalTrials.gov More Kidney Failure, Chronic trials