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

Renal Transplant Recipients Clinical Trial

Official title:

Efficacy and Safety of a Post-transplantation Switch From Cyclosporin to Tacrolimus Sustained-release Capsules in Renal Transplant Recipients: A Multi-center, Open-label, Uncontrolled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02706678
• Other study ID #: BJ309CT-02
• Status: Completed
• Phase: Phase 4
• Start date: December 29, 2010
• Est. completion date: August 1, 2012

Study information

• Verified date: July 2022
• Source: Astellas Pharma Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 105
• Est. completion date: August 1, 2012
• Est. primary completion date: August 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplant Recipients

Intervention

Drug:
• Tacrolimus sustained-release capsule
Oral

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Astellas Pharma China, Inc.

Country where clinical trial is conducted

China, 

Outcome

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

External Links

•   Link to results on Astellas Clinical Study Results website