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

Liver Transplantation Clinical Trial

— Prometheus  

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03596970
• Other study ID #: CRAD001HDE53
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 2015
• Est. completion date: December 2020

Study information

• Verified date: July 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• TAC withdrawal
Everolimus (RAD001) with MMF and Steroids
• Everolimus with reduced TAC
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants with adverse events	Routine safety will be assessed via AE reporting, vital signs, and laboratory data.	at 24 months (end of study)
Primary	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	Efficacy (tBPAR, graft loss, death, loss to follow-up)	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.	To Month 6