Kidney transplant drug showdown: which regimen saves more function?
NCT ID NCT01595984
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different combinations of immunosuppressant drugs in 88 adults who received a new kidney. The goal was to see which plan better protects kidney function over the short term. All participants took lifelong anti-rejection medication, so this is about managing the disease, not curing it.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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88 people
The number who actually took part.
- Started
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May 2012
- Finished
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Mar 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Males and Females aged between 18 and 70. * Patient receiving a first or second kidney transplant from a deceased donor, living related or unrelated. * Patient with a maximum PRA \<20%. * Patient wishing and being able to participate fully to the study, and having given a written consent. * Patient covered by a social insurance or beneficiary of such a regime. * Women of childbearing age must use a recognized method of contraception throughout the study period and continue for 8 weeks after discontinuation of study treatment. Exclusion Criteria: * Patient receiving a kidney from a heart attack donor , or an ABO incompatible donor or a donor with a positive T-cross match. * Patient with a maximum PRA\> 20% twice. * Cold ischemic time \> 36 hours. * Patients with thrombocytopenia (\<75000/mm3), neutropenia (\<1 500 / mm3), leukopenia (\<2 500 / mm3) or a hemoglobin concentration \<8 g / dl, at inclusion visit. * Patient with severe hyperlipidemia: total cholesterol ≥ 9 mmol / l (≥ 3.50 g / l) and / or triglycerides ≥ 8.5 mmol/l (≥ 7.5 g / l) despite appropriate lipid-lowering therapy. * Patient with known HIV positive status, know active hepatitis B or C. Recipients of an organ from a donor with positive HIV status, hepatitis B or hepatitis C are excluded. * Patient with severe systemic infections requiring continued therapy. * Treatment with an experimental drug within 4 weeks before the first dose of study treatment. * Patient for whom the initial disease or other pathology requires a long-term corticosteroid treatment. * Patient with a history of hypersensitivity or known contra-indications for macrolide or inhibitors of mTORs drugs; drugs similar to Myfortic ® (ERL080) or other components of the formulation such as lactose, or cyclosporine, or prednisone (Cortancyl ®), or Thymoglobuline ® or Iohexol. * Patient with a malignant disease or a history of malignancy over the past 5 years except squamous-cell or basal cell carcinoma wich was excised. * Medical condition or surgical procedure, except transplantation, which could exclude the patient in the opinion of the investigator. * Patient with symptoms of mental or significant somatic illness. Disability to cooperate or communicate with the investigator. * Pregnant, sucking or of childbearing age and refusing or being unable to use a recognized contraceptive method. * Patient under guardianship, or any patient protected by law.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Nephrology Department, University Hospital of Montpellier
Montpellier, 34285, France
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Nephrology department, Hospital University of Amiens
Amiens, 80000, France
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