Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients

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

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-29

Study Completion Date

2012-08-01

Brief Summary

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

The objective of this study is to evaluate the effects of tacrolimus sustained-release capsules replacing cyclosporin on kidney function of renal transplant recipients.

Related Clinical Trials

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

A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

NCT02268201

Kidney Transplant Recipients

TERMINATED PHASE4

A Study to Assess the Safety and Efficacy of a Tacrolimus Based Immunosuppressive Regimen in Stable Kidney Transplant Recipients Converted From Cyclosporine Based Immunosuppressive Regimen

NCT02963103

Kidney Transplantation

TERMINATED PHASE4

Conversion Study From Cyclosporine to FK506MR Based Immunosuppression in Kidney Transplant Subjects

NCT00481481

Transplantation

COMPLETED PHASE3

Study Evaluating Cyclosporine Dose Reduction and Cyclosporine Elimination in Chinese Kidney Transplants

NCT00257387

Kidney Transplant

COMPLETED PHASE1/PHASE2

A Study to Assess the Pharmacokinetics of a Modified-release Tacrolimus Based Immunosuppression Regimen in Stable Kidney Transplant Patients

NCT00282568

Kidney Transplantation

COMPLETED PHASE2

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.

Renal Transplant Recipients

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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

Tacrolimus sustained-release capsule group

Oral

Group Type EXPERIMENTAL

Tacrolimus sustained-release capsule

Intervention Type DRUG

Oral

Interventions

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

Tacrolimus sustained-release capsule

Oral

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

FK506

Eligibility Criteria

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

Inclusion Criteria

* 18-65 years of age, male or female
* 1-5 years after kidney transplantation
* The patient has been accepting cyclosporin-based immunosuppressive therapy for ≥6 months, and the therapeutic regimen has kept stable for at least 4 weeks before inclusion
* The dose of cyclosporin has kept stable for at least 4 weeks before inclusion
* At least one of the cyclosporin-related adverse reactions is present or the answer to the 5th question in the questionnaire is "Yes" at the time of inclusion:
* gingival hyperplasia and treatment requested by the patient
* polytrichia and interventional therapy requested by the patient
* post-transplantation hypertension
* post-transplantation hyperlipemia (total cholesterol\>5.7 mmol/L (220 mg/dl))
* Serum creatinine\<200 μmol/l ( 2.3 mg/dl)
* A promise is made to take contraceptive measures during the study (women at childbearing ages).

Exclusion Criteria

* Patients having accepted transplantation of other organs apart from kidney transplantation
* Patients with 24-hour urine protein\>2 g
* Patients with SGPT/ALT, SGOT/AST or total bilirubin continually increasing to more than twice the normal value(s)
* Patients with refractory infectious foci
* Patients with serious diarrhea or vomiting, active upper gastrointestinal ulcers or malabsorption
* Patients with serious heart or lung diseases or history of sugar tolerance abnormality or malignant tumors
* Patients allergic to tacrolimus or other basic medications
* Pregnant or lactating women
* Patients having participated in other clinical trials within the previous month
* Other patients who are considered by doctors unsuitable for the study

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No