Status:
COMPLETED
Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients
Lead Sponsor:
Astellas Pharma China, Inc.
Conditions:
Renal Transplant Recipients
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 29 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT02706678
Start Date
December 29 2010
End Date
August 1 2012
Last Update
November 8 2024
Active Locations (9)
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1
Beijing, China
2
Changchun, China
3
Chengdu, China
4
Guangzhou, China