Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.

A 24-month Multi-center, Open-label, Randomized, Controlled Study to Evaluate the Evolution of Renal Function in Maintenance Liver Transplant Recipients Receiving Either RAD001 (Everolimus) Plus Reduced TAC or RAD001 (Everolimus) Plus Mycophenolate Mofetil (MMF)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03596970

Acronym

Prometheus

Enrollment

Registered

2018-07-24

Start date

2015-09-30

Completion date

2020-12-31

Last updated

2018-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Transplantation

Keywords

Open-label, randomized, calcineurin-inhibitor, CNI, tacrolimus, MMF, maintenance liver transplant, RAD001H, CRAD001H, liver transplant, transplantation

Brief summary

A 24-month multi-center, open-label, randomized, controlled study to evaluate the evolution of renal function in maintenance liver transplant recipients receiving everolimus plus reduced TAC or everolimus plus mycophenolate mofetil (MMF)

Interventions

DRUGTAC withdrawal

Everolimus (RAD001) with MMF and Steroids

DRUGEverolimus with reduced TAC

Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients willing and capable of providing written informed consent for study participation. * Adults 18 to 70 years of age. * Liver allograft from a deceased or living donor. * Treated with a CNI containing immunosuppressive regimen. * Liver transplant 6 to 24 months prior to screening. * Estimated kidney function between chronic kidney disease (CKD) IIIb/ 30 mL/min \< eGFR \< CKD II/60 mL/min with deteriorating renal function. * Acceptable graft function (according to liver enzymes (AST / ALT) and total bilirubin).

Exclusion criteria

* Multiple solid organ transplant recipients * Active chronic inflammatory bowel disease and recurrent autoimmune hepatitis * Malignant diseases other than neoplasms of the skin. * Patient on other investigational drug or presence of any hypersensitivity to the interventional drug. * Pregnant or nursing (lactating) women. * Women of child-bearing potential (physiologically capable of becoming pregnant, unless they are using effective methods of contraception). * Anemia, thrombocytopenia, leucopenia, uncontrolled hyperlipidemia or proteinuria * HIV positivity Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame	Description
Renal Function	Randomization to Month 6	The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.

Secondary

Measure	Time frame	Description
Efficacy (tBPAR, graft loss, death, loss to follow-up)	To Month 6	Composite efficacy failure of tBPAR, graft loss, death or loss to follow-up and each of its components at month 6 will be analysed per event rate estimates, Kaplan-Meier and regression models. The time to the first occurrence of the event will be calculated from the randomization date.

Other

Measure	Time frame	Description
Number of participants with adverse events	at 24 months (end of study)	Routine safety will be assessed via AE reporting, vital signs, and laboratory data.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026