MedDataX Logo

Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients

NCT ID: NCT00171509

Last Updated: 2011-02-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-05-31

Study Completion Date

2005-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00171743

Liver Transplant
COMPLETED PHASE4

Conversion From Tacrolimus to Cyclosporine Microemulsion in Liver Transplant Patients With New Onset Diabetes After the 3rd Month Post-transplant

NCT00171717

Maintenance Liver Transplant Patients With New Onset Diabetes
COMPLETED PHASE4

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

NCT00332462

Liver Transplantation
COMPLETED PHASE4

Evaluation of Cyclosporine Microemulsion and Tacrolimus on the Rate of New Onset Diabetes Mellitus in Kidney Transplantation Recipients

NCT00171496

Kidney Transplant
COMPLETED PHASE4

Safety and Efficacy of Converting Maintenance Kidney and Liver Transplant Recipients With Abnormal Glucose Metabolism From Tacrolimus to Cyclosporine Micro-emulsion

NCT00150085

Tacrolimus-associated Abnormal Glucose Metabolism in Kidney and Liver Transplant Recipients
TERMINATED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Transplant

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BID cyclosporine

control group continuing with a BID administration of cyclosporine and C2 monitoring.

Group Type ACTIVE_COMPARATOR

Cyclosporine microemulsion

Intervention Type DRUG

OAD cyclosporine

conversion to OAD administration of cyclosporine with the same daily dose as received prior to conversion

Group Type EXPERIMENTAL

Cyclosporine microemulsion

Intervention Type DRUG

OAD cyclosporine reduced

OAD administration of cyclosporine with a daily dose adjusted to a reduced C2

Group Type EXPERIMENTAL

Cyclosporine microemulsion

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclosporine microemulsion

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Novartis Pharmaceuticals

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Novartis

Role: STUDY_DIRECTOR

Novartis

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COLO400A2421

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Renal Function Evaluation After Reduction of Cyclosporine A Dose in Renal Transplant Patients
NCT00213590 COMPLETED PHASE3
An Open Label Study to Evaluate the Tolerability and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion (CsA-ME) in Maintenance Renal Transplant Recipients
NCT00239044 COMPLETED PHASE3
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium After Equimolar Conversion From Mycophenolate Mofetil (MMF) in Patients With Renal Transplant
NCT00171379 COMPLETED PHASE3
Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants
NCT00257387 COMPLETED PHASE1/PHASE2
A One-year, Open Label Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients.
NCT00154245 COMPLETED PHASE4
Study of Enteric-coated Mycophenolate Sodium Maintenance Therapy in Patients With Renal Transplant Receiving Cyclosporine Microemulsion and Steroids,
NCT00239057 COMPLETED PHASE3
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in de Novo Kidney Transplant Recipients
NCT00312143 COMPLETED PHASE4
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
NCT00239785 COMPLETED PHASE3
Pharmacokinetics of Everolimus and Enteric-Coated Mycophenolatesodium Before and After Withdrawal of Cyclosporine in Renal Transplant Patients
NCT00443937 COMPLETED PHASE4
Clinical Study to Evaluate the Tolerability, Safety and Efficacy of Enteric-coated Mycophenolate Sodium, After Equimolar Conversion From Mycophenolate Mofetil (MMF), in Patients With Stable Renal Transplant Receiving Tacrolimus
NCT00171392 COMPLETED PHASE3
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
NCT00170885 COMPLETED PHASE4
Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
NCT00238940 COMPLETED PHASE3
Efficacy and Safety of Enteric-coated Mycophenolate Sodium (EC-MPS) in a Cyclosporine Microemulsion Based Regimen in de Novo Living Donor Kidney Transplant Recipients
NCT00537862 COMPLETED PHASE4
Study of Pharmacogenomic-Guided Tacrolimus Dosing and Monitoring in Kidney Transplant Recipients
NCT03020589 COMPLETED PHASE4
Efficacy and Safety of Enteric-coated Mycophenolate Sodium and Cyclosporine in Combination With and Without Steroids, in Adult Renal Transplant Recipients
NCT00413920 COMPLETED PHASE3
Study of the Pharmacokinetics of Mycophenolate Mofetil in Patients Who Have Undergone Orthotopic Liver Transplantation
NCT00007059 COMPLETED NA
Reduction in the Risk of Rejection by Mycophenolate Mofetil Dose Adjustment in Liver Transplant Patients With Side Effects Caused by the Calcineurine Inhibitors
NCT00456235 COMPLETED PHASE4
Effect of Cyclosporine A Versus Tacrolimus on Response to Antiviral Therapy After Hepatitis C Genotype -4 Recurrence Post Liver Transplantation
NCT03665766 COMPLETED
Therapeutic Drug Monitoring (TDM) of Cyclosporine in Kidney Transplant Patients by Dried Blood Spot Assay. Interest and Feasibility.
NCT02830191 COMPLETED
Study Evaluating the Efficacy and Safety of Cyclosporine Reduction in Kidney Transplant Recipients Receiving Sirolimus
NCT00507793 COMPLETED PHASE4
Pharmacokinetics of Tacrolimus in Kidney Transplant Recipients: Once Daily Versus Twice Daily Dosing
NCT00028171 COMPLETED NA
Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients
NCT00149994 COMPLETED PHASE4
A Study to Investigate the Tolerability and Safety of Converting Stable Renal Transplant Recipients Who Receive Tacrolimus With or Without Corticosteroids From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS)
NCT00238979 COMPLETED PHASE4
Intensified vs. Standard Dose Therapy With Mycophenolate Sodium Plus Cyclosporin Microemulsion and Corticosteroid Combination in Patients With de Novo Renal Transplant Patients
NCT00369278 COMPLETED PHASE3
Efficacy and Tolerability of Full Dose Enteric-coated Mycophenolate Sodium, in Addition to Cyclosporine for Microemulsion Reduced Dose, in Maintenance Renal Transplant Recipients
NCT00434590 TERMINATED PHASE4