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NCT00171743 Clinical Trial

Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients

Liver Transplant Clinical Trial

Official title:
Switch From Tacrolimus to Cyclosporine Microemulsion: Immunosuppressive Agents and Diabetes Management in Liver Transplant Recipients in Maintenance (DIALIVER)

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00171743
Other study ID # COLO400AIT03
Secondary ID
Status Completed
Phase Phase 4
First received September 13, 2005
Last updated June 5, 2017
Start date April 2004
Est. completion date January 2006

Study information
Verified date June 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 47
Est. completion date January 2006
Est. primary completion date January 2006
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- At least 4 months post-transplant

- Patients in treatment with tacrolimus

- Post-transplant diabetes treated with insulin for at least one month

Exclusion Criteria

- Known hypersensitivity to cyclosporine microemulsion

- Investigational drug within 60 days before baseline or during the study

- Patients who cannot comply with the study requirements

Other protocol-defined exclusion criteria applied

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Cyclosporine microemulsion

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Novartis

References & 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. — View Citation

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