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

Phase 4

Completed

• Conditions: Renal Transplant Recipients
• Interventions: Drug: Tacrolimus sustained-release capsule

• Registration Number: NCT02706678
• Lead Sponsor: Astellas Pharma China, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-29
• Primary Completion: 2012-08-01
• Study Completion: 2012-08-01
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-07
• Last Update Posted: 2024-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus sustained-release capsule group	Tacrolimus sustained-release capsule	Oral

Primary Outcome Measures

Name	Time	Method
Change from baseline in creatinine level	Baseline and Week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in polytrichia	Baseline and Week 24
Change from baseline in fasting blood glucose	Baseline and Weeks 1, 2, 4, 8, 12 and 24
Change from baseline in gingival hyperplasia	Baseline and Week 24
Change from baseline in creatinine level	Baseline and Weeks 1, 2, 4, 8 and 12
Incidence of rejection reaction after drug use	Up to Week 24
Change from baseline in blood pressure	Baseline and Weeks 1, 2, 4, 8, 12 and 24	Diastolic pressure and systolic pressure
Plasma concentrations of tacrolimus	Weeks 1, 2, 4, 8, 12 and 24
Safety assessed by Adverse Events	Up to 24 weeks
Change from baseline in blood lipid	Baseline and Weeks 1, 2, 4, 8, 12 and 24	Total cholesterol, high density lipoprotein, low density lipoprotein, triglyceride
Change from baseline in liver function	Baseline and Weeks 1, 2, 4, 8, 12 and 24	Aspartate aminotransferase, alanine aminotransferase, bilirubin