Trial record 7 of 161 for:
Open Studies | "liver transplantation"
Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients
This study is not yet open for participant recruitment.
Verified July 2012 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01598987
First received: March 1, 2012
Last updated: July 31, 2012
Last verified: July 2012
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Purpose
This study is designed to assess the evolution of renal function and to collect efficacy, safety, and tolerability data of everolimus in co-exposure with reduced CNI in paediatric liver transplant recipients.
| Condition | Intervention | Phase |
|---|---|---|
|
Renal Function Liver Transplant |
Drug: Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation. |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A 24-month, Multi-center, Single Arm, Prospective Study to Evaluate Renal Function, Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in Glomerular Filtration Rate [ Time Frame: baseline, 12-month after start of study drug ] [ Designated as safety issue: No ]Renal function assessed by estimated Glomerular Filtration Rate 12-month after start of study drug.
Secondary Outcome Measures:
- Rate of composite efficacy failure of treated biopsy proven acute rejection (tBPAR), graft loss (GL) or death (D). [ Time Frame: baseline, 12-month after start of study drug ] [ Designated as safety issue: No ]Efficacy failure rate of tBPAR, GL, or D.at 12-month after start of study drug
- Number of Adverse Events [ Time Frame: baseline, 12-month and 24-month after start of study drug ] [ Designated as safety issue: Yes ]
AE/SAEs as per preferred term and system organ class Incidence of treatment-related side effects Incidence and reason (e.g. AE) for premature discontinuation of study medication, and premature withdrawal from the study.
Incidence and reason (e.g. AE) for dose interruption and dose adjustment of study medication.
| Estimated Enrollment: | 175 |
| Study Start Date: | July 2012 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Everolimus based regimen
Conversion at Baseline from an immunosuppressive regimen which contains either cyclosporine (CsA) or tacrolimus (TAC) with or without mycophenolic acid (MPA), with or without corticosteroids in a regimen which contains everolimus combined reduced dose of either cyclosporine (CsA) or tacrolimus (TAC).
|
Drug: Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.
Immunosuppression after liver transplantation.
|
Eligibility| Ages Eligible for Study: | 1 Month to 17 Years |
| Genders Eligible for Study: | Both |
Criteria
Key Inclusion Criteria:
- Signed informed consent from both parents or legal guardian(s) prior to patient participation in the study.
- Paediatric liver transplant recipients aged greater than or equal to 1 month and younger than 18 years of age.
- Paediatric recipients at the earliest 1 month and latest 6 month after liver transplantation.
Key Exclusion Criteria:
- Patients with hepato-biliary malignancies and/or patients transplanted due to fulminant hepatitis /acute liver failure.
- Presence of thrombosis of any major hepatic arteries, major/reconstructed hepatic veins, portal vein or inferior vena cava at any time prior to the start of study drug.
- Patients with serum creatinine value > 2 times age-related ULN at Baseline or who received renal replacement therapy within one week prior to the start of study drug and patients with a confirmed spot urine protein/creatinine ratio indicating a urinary protein excretion > 500 mg/m2/24 hrs, at Baseline.
- Patients with clinically significant systemic infection and/or in a critical care setting requiring life support measures such as mechanical ventilation, dialysis, or vasopressor agents.
- Patients with a known hypersensitivity to the drugs used on study or their class, or to any of the excipients.
- Pregnant or nursing (lactating) female patients, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive βHCG laboratory test (> 9 mIU/mL) at Baseline.
- Female patients of child-bearing potential, defined as all women physiologically capable of becoming pregnant, UNLESS they agree for abstinence from sexual activity.
Contacts and Locations
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More Information
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| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01598987 History of Changes |
| Other Study ID Numbers: | CRAD001H2305, 2011-003069-14 |
| Study First Received: | March 1, 2012 |
| Last Updated: | July 31, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Paediatric liver transplantation Everolimus Reduced calcineurin inhibitor |
Cyclosporine, tacrolimus Renal function composite efficacy endpoint (biopsy proven acute rejection death, graft loss) |
Additional relevant MeSH terms:
|
Cyclosporins Cyclosporine Everolimus Sirolimus Tacrolimus Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Therapeutic Uses Dermatologic Agents Antirheumatic Agents Antibiotics, Antineoplastic Antineoplastic Agents Anti-Bacterial Agents |
ClinicalTrials.gov processed this record on May 22, 2013