Clinical trial · Interventional
Calcineurin Inhibitor (CNI) Versus Steroid Cessation in Renal Transplantation
Impact of Cyclosporine or Steroid Withdrawal at 3 Months Post Transplantation on Graft Function, Patient Survival and Cardiovascular Surrogate Markers the First 5 Years After Renal Transplantation.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study intends to determine whether steroid withdrawal or calcineurin inhibitor withdrawal is superior for graft function and graft survival. Secondary endpoints for this study are: incidence of tumors and cardiovascular events. The primary objective: To assess if superior graft function (glomerular filtration rate (GFR) difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
| Everolimus | Drug | Everolimus | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Cyclosporine
- description
- Simulect + cyclosporine + Myfortic + steroid stop at 3 months
- interventionNames
- Drug: cyclosporine
- type
- ACTIVE_COMPARATOR
- label
- Everolimus
- description
- Simulect + cyclosporine (decrease dose in one week at month 3 and replace by Everolimus (Certican)) + Myfortic + steroid maintenance
- interventionNames
- Drug: Everolimus
Primary outcomes (1)
- measure
- To assess if superior graft function (GFR difference of 10 ml/min) will be achieved at 1 year after transplantation in cohorts of de novo kidney transplant patients treated with Myfortic-everolimus plus steroids compared to Myfortic-cyclosporine.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Male or female recipients of a de novo kidney transplant, aged above 18 years * Women of childbearing potential must have a negative serum or urine pregnancy test with sensitivity equal to at least 50 mIU/ml * Patients must be capable of understanding the purpose and risks of the study, and must sign an informed consent form Exclusion Criteria: * Multiple organ transplantation (e.g., Kidney-pancreas, kidney-heart, kidney- liver,...) * Transplantation of a patient who got another organ transplant previously * Recipients of a HLA-identical living-related renal transplant * Patients with PRA \> 30%, patients who have lost a first graft from rejection within two years after transplantation, and African European patients. * Patients with primary renal disease at risk for recurrence: FSGS, MPGN, HUS * Pregnant or lactating women * WBC \< 2.5 x 109/l (IU), platelet count \< 100 x 109/l (IU), or Hb \< 6 g/dl at the time of entry into the study * Active peptic ulcer * Severe diarrhea or other gastrointestinal disorder, which might interfere with their ability to absorb oral medication, including diabetic patients with previously diagnosed diabetic gastroenteropathy * Known HIV-1 or HTLV-1 positive tests * The use of investigational drugs or other immunosuppressive drugs, as those specified in this protocol * Patients receiving bile acid sequestrants * Psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study
References
Publications (1)
- DERIVEDPipeleers L, Abramowicz D, Broeders N, Lemoine A, Peeters P, Van Laecke S, Weekers LE, Sennesael J, Wissing KM, Geers C, Bosmans JL. 5-Year outcomes of the prospective and randomized CISTCERT study comparing steroid withdrawal to replacement of cyclosporine with everolimus in de novo kidney transplant patients. Transpl Int. 2021 Feb;34(2):313-326. doi: 10.1111/tri.13798. Epub 2020 Dec 31. PMID 33277746