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NCT01609673
Evaluation of the Early Conversion From a Calcineurin Inhibitor-based Immunosuppressive Regimen to Everolimus in de Novo Renal Transplant Recipients, a Multicenter Experience
NA trial testing Everolimus in End Stage Renal Failure With Renal Transplant in 1 participant. Terminated before completion.
1 May 2013
Quick facts
| Lead sponsor | Helady Pinheiro, MD, PhD |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 1 |
| Start date | 1 March 2013 |
| Primary completion | 1 May 2013 |
| Estimated completion | 1 May 2013 |
| Sites | 4 locations across Brazil |
Drugs / interventions tested
- Everolimus (everolimus) — full drug profile →
Conditions studied
- End Stage Renal Failure With Renal Transplant — all drugs for End Stage Renal Failure With Renal Transplant →
Sponsor
Helady Pinheiro, MD, PhD
Who can join
Adults 18 to 85, any sex, with End Stage Renal Failure With Renal Transplant. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in estimated glomerular filtration rate (eGFR)
Time frame: 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus
The eGFR will be calculated by Cockcroft-Gault, CKD-EPI and MDRD equations, firstly 4-5 months after transplantation (baseline), and then 6 and 12 months after conversion to everolimus (Certican ®) and suspension of CNI, associated with Myfortic ® (mycophenolate sodium enteric-coated - MSEC).
Sponsor's own description
In the present study, the investigators propose a conversion scheme with 50% reduction in CNI dosage until adjustment of everolimus dosage, in order to reach a trough blood level of 6-10 ng/mL, thus avoiding overimmunosuppression or alternatively breakthrough rejection episodes. The hypothesis of this study is to demonstrate that the therapeutic regimen with Myfortic® and Certican® significantly improves renal function compared with the standard regimen of CNI.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01609673
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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- NCT07477548 — A Study to Evaluate the Efficacy and Safety of Everolimus in Patients With Teratment-refractory Vascular Anomalies · Phase 2 · not yet recruiting
- NCT07405164 — Extension Study for Participants in Studies That Include Belzutifan (MK-6482-043/LITESPARK-043) · Phase 3 · recruiting
- NCT06832189 — EVR and EPO for Liver Transplant Tolerance · Phase 1 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01609673 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Helady Pinheiro, MD, PhD
- Last refreshed: 11 June 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01609673.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing