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

NCT02706678 | Completed Phase 4

• 1 other identifier: BJ309CT-02
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 9

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.

Conditions

Renal Transplant Recipients

Keywords

FK506; Renal transplant recipients; cyclosporin

Outcome Measures

Primary Outcomes (1)

• Change from baseline in creatinine level

  Baseline and Week 24

Secondary Outcomes (10)

• 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

• Plasma concentrations of tacrolimus

  Weeks 1, 2, 4, 8, 12 and 24

• Change from baseline in blood pressure

  Baseline and Weeks 1, 2, 4, 8, 12 and 24

• Change from baseline in blood lipid

  Baseline and Weeks 1, 2, 4, 8, 12 and 24

Study Arms (1)

Tacrolimus sustained-release capsule group

EXPERIMENTAL

Oral

Drug: Tacrolimus sustained-release capsule

Interventions

Tacrolimus sustained-release capsule DRUG

Oral

Also known as: FK506

Tacrolimus sustained-release capsule group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age, male or female
• years after kidney transplantation
• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Astellas Pharma China, Inc.: lead

Study Sites (9)

Unknown Facility

Beijing, China

Location

Unknown Facility

Changchun, China

Location

Unknown Facility

Chengdu, China

Location

Unknown Facility

Guangzhou, China

Location

Unknown Facility

Nanjing, China

Location

Unknown Facility

Nanning, China

Location

Unknown Facility

Shanghai, China

Location

Unknown Facility

Shenyang, China

Location

Unknown Facility

Wuhan, China

Location

Related Links

• Link to results on Astellas Clinical Study Results website

MeSH Terms

Interventions

Tacrolimus

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals

Study Officials

• Medical Director

  Astellas Pharma Inc

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2016
• First Posted: March 11, 2016
• Study Start: December 29, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (9)