NCT01878786 (Evered) is a Phase 2/Phase 3 clinical trial of Everolimus in Delayed Graft Function, sponsored by Matthew Cooper.

Who is sponsoring NCT01878786?

NCT01878786 is sponsored by Matthew Cooper.

What drugs are being tested in NCT01878786?

Interventions in NCT01878786: Everolimus, Tacrolimus, Mycophenolate mofetil (MMF/MPA).

What condition does NCT01878786 study?

NCT01878786 studies Delayed Graft Function.

Is NCT01878786 still recruiting?

NCT01878786 is currently terminated. Last updated 4 April 2019.

Are results published for NCT01878786?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2019-04-04 · How we verify

NCT01878786: Evered

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Pilot Study Comparing the Safety and Efficacy of Zortress (Everolimus) With Low Dose Tacrolimus to Early Conversion to Calcineulin Inhibitor-Free Regimen and Mycophenolic Acid With Standard Dose Tacrolimus in Recipients of ECD/DCD Kidneys

Terminated Phase 2/Phase 3 Results posted Last updated 4 April 2019

What this trial tests

Phase 2/Phase 3 trial testing Everolimus in Delayed Graft Function in 25 participants. Terminated before completion.

Timeline

1 June 2013

Primary endpoint
1 November 2017

1 December 2017

Quick facts

Lead sponsor	Matthew Cooper
Phase	Phase 2/Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	25
Start date	1 June 2013
Primary completion	1 November 2017
Estimated completion	1 December 2017
Sites	1 location across United States

Drugs / interventions tested

Everolimus (everolimus) — full drug profile →
Tacrolimus (TACROLIMUS) — full drug profile →
Mycophenolate mofetil (MMF/MPA) — full drug profile →

Conditions studied

Delayed Graft Function — all drugs for Delayed Graft Function →

Sponsor

Matthew Cooper — full company profile →

Who can join

Adults 18 to 65, any sex, with Delayed Graft Function. 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.

Evaluate Concentration-controlled Everolimus and Low Dose Tacrolimus Compared to MMF/MPA With Standard Dose Tacrolimus at 24 Months
Time frame: 24 months
The primary objective of this study is to evaluate concentration-controlled everolimus and low dose tacrolimus compared to MMF/MPA with standard dose tacrolimus at 24 months post-transplant with respect to the composite efficacy failure rates (treated biopsy proven acute rejection episodes (BPAR), graft loss, death, loss to follow-up) in de novo renal transplant recipients.

Sponsor's own description

The purpose of this pilot study is to evaluate concentration-controlled everolimus with low dose tacrolimus compared to early conversion to CNI-free regimen and MMF/MPA with standard dose tacrolimus in de novo renal transplant recipients of ECD/DCD kidneys. Given tacrolimus and MMF/MPA is a widely prescribed immunosuppressive regimen in the United States, comparisons of tacrolimus and MMF/MPA regimens to investigational therapies and treatment regimens are needed. Also, considering the fact that ECD/DCD is a fast growing fraction of donors, evaluation of various regimens' effects on rather delicate ECD/DCD kidneys is necessary.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Everolimus

Trials testing the same drug.

NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
NCT07318324 — Phase Ib Study of Avutometinib, Defactinib, and Everolimus in RAS Pathway Mutant Endometrial Cancer · Phase 1 · not yet recruiting
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

Other recruiting trials for Delayed Graft Function

Currently open trials in the same condition.

NCT07275632 — The Effects of Vonoprazan Fumarate on DGF Incidence in DD Kidney Transplant Recipients · Phase 1, PHASE2 · recruiting
NCT06830798 — Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab Admin · Phase 3 · recruiting
NCT06367205 — Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations · NA · recruiting
NCT05907096 — ARGX-117 in Deceased Donor Kidney Transplant Recipients at Risk for Delayed Graft Function · Phase 2 · active not recruiting
NCT05430620 — Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys · Phase 3 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01878786 (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 Matthew Cooper
Last refreshed: 4 April 2019

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/NCT01878786.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing