NCT00171743

Brief Summary

The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Apr 2004

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

April 1, 2004

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

June 7, 2017

Status Verified

June 1, 2017

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

June 5, 2017

Conditions

Liver Transplant

Keywords

AdultsPost transplant diabetes

Interventions

Cyclosporine microemulsionDRUG

Eligibility Criteria

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

You may qualify if:

  • At least 4 months post-transplant
  • Patients in treatment with tacrolimus
  • Post-transplant diabetes treated with insulin for at least one month

You may not qualify if:

  • Known hypersensitivity to cyclosporine microemulsion
  • Investigational drug within 60 days before baseline or during the study
  • Patients who cannot comply with the study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Rathi M, Rajkumar V, Rao N, Sharma A, Kumar S, Ramachandran R, Kumar V, Kohli HS, Gupta KL, Sakhuja V. Conversion from tacrolimus to cyclosporine in patients with new-onset diabetes after renal transplant: an open-label randomized prospective pilot study. Transplant Proc. 2015 May;47(4):1158-61. doi: 10.1016/j.transproceed.2014.12.050.

    PMID: 26036543RESULT

Study Officials

  • Novartis

    Novartis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

April 1, 2004

Primary Completion

January 1, 2006

Study Completion

January 1, 2006

Last Updated

June 7, 2017

Record last verified: 2017-06