NCT00154193

Brief Summary

The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2 levels to outcome (renal function and incidence of acute rejections)

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 12, 2005

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Last Updated

February 11, 2020

Status Verified

April 1, 2016

Enrollment Period

3.4 years

First QC Date

September 6, 2005

Last Update Submit

February 8, 2020

Conditions

Heart and Lung Transplant

Keywords

Heart transplant, lung transplant, renal function, cyclosporine C2 Levels

Outcome Measures

Primary Outcomes (2)

  • The average number of treated acute cardiac and lung graft rejection per patient during the first 12 months post transplant

  • The measured Glomerular Filtration Rate (GFR) at 3 and 12 months post-transplant

Secondary Outcomes (3)

  • Incidence of treated acute rejections

  • Incidence of biopsy-proven acute cellular rejections

  • Patient and Graft survival rates

Study Arms (1)

Cyclosporine

ACTIVE COMPARATOR
Drug: cyclosporine

Interventions

cyclosporineDRUG

patients will receive maintenance triple immunosuppression according to local practice consisting of Sandimmun Neoral, MMF/ECMPA or azathioprin and steroids.

Cyclosporine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients receiving a first heart or bilateral or single lung transplant
  • Patients for whom a triple maintenance immunosuppressive therapy consisting of cyclosporine microemulsion, steroids and mycophenolate mofetil (MMF)/ enteric-coated mycophenolate sodium (EC-MPS ,(or azathioprine) is indicated.

You may not qualify if:

  • Multi-organ transplants or previously transplanted organs
  • Patients with the need of more than two cyclosporine microemulsion dosages per day

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis

Basel, Switzerland

Location

Related Publications (1)

  • Iversen M, Nilsson F, Sipponen J, Eiskjaer H, Mared L, Bergan S, Nystrom U, Fagertun HE, Solbu D, Simonsen S. Cyclosporine C2 levels have impact on incidence of rejection in de novo lung but not heart transplant recipients: the NOCTURNE study. J Heart Lung Transplant. 2009 Sep;28(9):919-26. doi: 10.1016/j.healun.2009.05.022.

    PMID: 19716045DERIVED

MeSH Terms

Interventions

Cyclosporine

Intervention Hierarchy (Ancestors)

CyclosporinsPeptides, CyclicMacrocyclic CompoundsPolycyclic CompoundsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 6, 2005

First Posted

September 12, 2005

Study Start

June 1, 2004

Primary Completion

November 1, 2007

Last Updated

February 11, 2020

Record last verified: 2016-04

Locations

CH(1)