Study of the Effect of Everolimus Immunosuppressive Combination Therapies on Renal Function When Used as a Maintenance Treatment for Liver Transplant Patients.
NCT ID: NCT03596970
Last Updated: 2018-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2015-09-30
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Everolimus with MMF (TAC-withdrawal)
Everolimus (RAD001) with MMF and Steroids
TAC withdrawal
Everolimus (RAD001) with MMF and Steroids
Everolimus with reduced TAC
Everolimus (RAD001) with reduced TAC and Steroids
Everolimus with reduced TAC
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids
Interventions
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TAC withdrawal
Everolimus (RAD001) with MMF and Steroids
Everolimus with reduced TAC
Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Other Identifiers
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CRAD001HDE53
Identifier Type: -
Identifier Source: org_study_id
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