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Completed

NCT Number: NCT00332462

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

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.

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Key information

Conditions

Liver Transplantation

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigational Site

Various Cities, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cyclosporine (Sandimmun® i.v.)

Drug

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 names: Sandimmun

Cyclosporine (Sandimmun® Optoral)

Drug

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 names: Sandimmun

Primary outcomes

  1. Incidence of Biopsy Proven Acute Rejection During the First 3 Months Post de Novo Liver Transplantation

    Time frame: 3 months

    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 outcomes

  1. 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

    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.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2008
Study completion
2009
First posted
Jun 1, 2006
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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