Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00171509 |
Recruitment Status
:
Completed
First Posted
: September 15, 2005
Last Update Posted
: February 1, 2011
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Transplant | Drug: Cyclosporine microemulsion | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 61 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | A Multicenter, Randomized Open-label Pilot Study to Explore the Benefit of a Conversion From a Twice a Day Administration of Cyclosporine Microemulsion to a Once a Day Administration and to Identify the C2 Ranges to Target After Conversion in Stable Liver Transplant Recipients |
Study Start Date : | May 2004 |
Actual Primary Completion Date : | October 2005 |
Actual Study Completion Date : | October 2005 |

Arm | Intervention/treatment |
---|---|
Active Comparator: BID cyclosporine
control group continuing with a BID administration of cyclosporine and C2 monitoring.
|
Drug: Cyclosporine microemulsion |
Experimental: OAD cyclosporine
conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion
|
Drug: Cyclosporine microemulsion |
Experimental: OAD cyclosporine reduced
OAD administration of cyclosporine with a daily dose adjusted to a reduced C2
|
Drug: Cyclosporine microemulsion |
- Investigation of the proportion of patients with an improving GFR in the groups converted to OAD in comparison with the BID group 15 weeks after conversion.
- assess the safety of a once a day administration of cyclosporine microemulsion.
- compare for each patient the C2 levels pre- and post-conversion.
- characterize the steady state pharmacokinetics of cyclosporine after conversion to once a day administration.
- the proportion of patients with improving renal function or blood pressure or lipid levels or glucose control (as a composite end point as well as each parameter assessed individually) [ Time Frame: 4 months ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Inclusion Criteria:
- At least 6 months post-transplant
- At least one of the following: stable or deteriorating kidney function, high blood pressure, high lipids, high glucose
- Receiving stable doses of cyclosporine microemulsion for the past 3 months
Exclusion Criteria:
- - Severe rejection within the past 3 months
- Severe kidney dysfunction
- Transplanted for hepatitis C or autoimmune hepatitis
Other protocol-defined exclusion criteria applied

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00171509
Study Director: | Novartis | Novartis |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00171509 History of Changes |
Other Study ID Numbers: |
COLO400A2421 |
First Posted: | September 15, 2005 Key Record Dates |
Last Update Posted: | February 1, 2011 |
Last Verified: | January 2011 |
Keywords provided by Novartis:
Liver transplant, adults, once a day administration, Immunosuppressants |
Additional relevant MeSH terms:
Cyclosporins Cyclosporine Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Immunosuppressive Agents Immunologic Factors |
Physiological Effects of Drugs Antifungal Agents Anti-Infective Agents Dermatologic Agents Antirheumatic Agents Calcineurin Inhibitors |