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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03596970
Other study ID # CRAD001HDE53
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
Start date September 2015
Est. completion date December 2020

Study information

Verified date July 2018
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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