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A Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine in de Novo Liver Transplant Recipients

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00332462
First received: May 30, 2006
Last updated: March 1, 2011
Last verified: March 2011
History of Changes
  Purpose

The aim of this exploratory study is to evaluate the rejection rate in patients treated with cyclosporine (CsA) preceding oral administration of cyclosporine micro emulsion in de novo liver recipients. The blood levels of CsA and CsA micro emulsion will be monitored by C-2h monitoring. In addition, this study will assess the safety of this treatment regimen.


Condition Intervention Phase
Liver Transplantation
 Drug: Cyclosporine (Sandimmun® i.v.)
Drug: Cyclosporine (Sandimmun® Optoral)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Exploratory Study to Evaluate the Efficiency of Intravenously Administered Cyclosporine During the First 7 Days Post Transplant Followed by Treatment With Cyclosporine Micro Emulsion in de Novo Liver Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Number of patients with biopsy proven acute rejection (BPAR) within 3 months after post de novo liver transplantation. In all suspected rejection episodes an allograft biopsy was performed within a 48 hour period of initiation of an anti-rejection therapy. A designated pathologist graded the biopsies according to the Banff criteria into mild, moderate or severe BPAR.


Secondary Outcome Measures:
  • Incidence, Safety and Tolerability of Cyclosporine Intravenous (i.v.) During 6 Months Post de Novo Liver Transplantation [ Time Frame: 3 or 6 months after transplantation ] [ Designated as safety issue: Yes ]
    The secondary efficacy endpoints included: the incidence of BPAR at 6 months; the incidence of treated acute rejection (TAR) / steroid-resistant acute rejection at 3 and 6 months; the incidence of BPAR with moderate/severe histological grading at 3 and 6 months; time to the first BPAR, the first TAR / steroid-resistant acute rejection and BPAR with moderate/severe histological grading; patient death at 3 and 6 months; and graft loss at 3 and 6 months.


Enrollment: 34
Study Start Date: May 2006
Study Completion Date: January 2009
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cyclosporine (Sandimmun®)
Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
 Drug: Cyclosporine (Sandimmun® i.v.)
Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Other Name: Sandimmun
Drug: Cyclosporine (Sandimmun® Optoral)
Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
Other Name: Sandimmun

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • About to undergo a primary liver transplant (including living donor, split liver).
  • Expected to be capable of study participation for full 6 months post-transplantation.
  • Allograft biopsies will be possible.

Exclusion Criteria

  • The surgery is a multi-organ transplant.
  • The patient has previously been transplanted with any other organ.
  • The graft derives from a non-heart beating donor.

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00332462

Locations
Germany
Novartis Investigational Site
Various Cities, Germany
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Novartis
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00332462     History of Changes
Other Study ID Numbers: COLO400ADE01
Study First Received: May 30, 2006
Results First Received: December 13, 2010
Last Updated: March 1, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
Liver transplantation, Cyclosporine

Additional relevant MeSH terms:
Cyclosporins
Cyclosporine
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

ClinicalTrials.gov processed this record on May 19, 2013