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

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ClinicalTrials.gov Identifier: NCT03596970
Recruitment Status : Withdrawn
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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)

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: TAC withdrawal Drug: Everolimus with reduced TAC Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020


Arm Intervention/treatment
Experimental: Everolimus with MMF (TAC-withdrawal)
Everolimus (RAD001) with MMF and Steroids
Drug: TAC withdrawal
Everolimus (RAD001) with MMF and Steroids

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




Primary Outcome Measures :
  1. Renal Function [ Time Frame: Randomization to Month 6 ]
    The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.


Secondary Outcome Measures :
  1. Efficacy (tBPAR, graft loss, death, loss to follow-up) [ Time Frame: 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 Outcome Measures:
  1. Number of participants with adverse events [ Time Frame: at 24 months (end of study) ]
    Routine safety will be assessed via AE reporting, vital signs, and laboratory data.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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/exclusion criteria may apply.


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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03596970     History of Changes
Other Study ID Numbers: CRAD001HDE53
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
maintenance liver transplant
liver transplant
transplantation
Open-label
randomized
calcineurin-inhibitor
CNI
tacrolimus
MMF
RAD001H
CRAD001H

Additional relevant MeSH terms:
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Everolimus
Sirolimus
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents