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

NCT03596970 | Withdrawn Phase 3 DMC

• 1 other identifier: CRAD001HDE53
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Liver Transplantation

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Renal Function

  The primary variable will be the mean change in renal function assessed by eGFR from randomization to Month 6.

  Randomization to Month 6

Secondary Outcomes (1)

• Efficacy (tBPAR, graft loss, death, loss to follow-up)

  To Month 6

Other Outcomes (1)

• Number of participants with adverse events

  at 24 months (end of study)

Study Arms (2)

Everolimus with MMF (TAC-withdrawal)

EXPERIMENTAL

Everolimus (RAD001) with MMF and Steroids

Drug: TAC withdrawal

Everolimus with reduced TAC

ACTIVE COMPARATOR

Everolimus (RAD001) with reduced TAC and Steroids

Drug: Everolimus with reduced TAC

Interventions

TAC withdrawal DRUG

Everolimus (RAD001) with MMF and Steroids

Everolimus with MMF (TAC-withdrawal)

Everolimus with reduced TAC DRUG

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

Everolimus with reduced TAC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Interventions

Everolimus

Intervention Hierarchy (Ancestors)

Sirolimus; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2015
• First Posted: July 24, 2018
• Study Start: September 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 24, 2018

Record last verified: 2018-07