Kidney Transplant Recipients Clinical Trial
Official title:
A Randomized, Open-label, Multi-center Clinical Trial to Compare Efficacy and Safety of Cyclosporine-based and Switching Cyclosporine to Tacrolimus of Two Forms-based Immunosuppressive Therapy in Renal Transplant (KTx) Recipients
Verified date | January 2019 |
Source | Astellas Pharma Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
KTx recipients receiving cyclosporine-based immunosuppressive therapy, and in the opinion of the investigator would benefit from switch to a tacrolimus-based immunosuppression, will switch the immunosuppressive therapy to a tacrolimus-based one. Efficacy and safety of patients will be observed for 52 weeks.
Status | Terminated |
Enrollment | 17 |
Est. completion date | March 31, 2015 |
Est. primary completion date | March 31, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients have received cyclosporine-based immunosuppressive therapy for more than 6 months, and have maintained a stable regimen for at least 8 weeks before enrollment - The trough blood level of cyclosporine maintained at 50-200ng/ml at least 4 weeks before enrollment - SCr< 200 µmol/l ( 2.3 mg/dl) - Females of childbearing potential must have a negative pregnancy test within 48 hrs prior to randomization and reliable methods of contraception should be started 4 weeks prior to and during the whole study - Understand and sign the approved informed consent form Exclusion Criteria: - Patients who have had other solid organ transplantations - 24 hours proteinuria>2g - SGPT/ALT,SGOT/AST or total bilirubin rising to more than double the normal level - Patients suffering from serious infection lesions - Patients have severe diarrhea or vomiting, peptic ulcer and/or defective absorption - Patients have severe heart, lung disease, abnormal glucose tolerance or malignant tumor history - Known contraindication to administration of Tacrolimus. Subject has known hypersensitivity to tacrolimus, or any of the product excipients - Pregnancy or lactating women - Patients have participated in another clinical trial in the past month - Patient refuses to sign informed consent form - Patient not willing to continue in the study and wants to withdraw from the study - Poor adherence or lost to follow-up - Violation of protocol - Severe adverse events occurred need to withdraw the study according to investigator's judgment - Pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Astellas Pharma China, Inc. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | medication adherence | VAS will be used to evaluate adherence between PRG and ADV | Up to 52 weeks after switching | |
Secondary | endogenous creatinine clearance rate (Ccr) | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | ||
Secondary | Calculated glomerular filtration rate | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | ||
Secondary | blood lipids | total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglyceride | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | |
Secondary | liver function (AST, ALT and bilirubin) | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | ||
Secondary | fasting blood-glucose (FBG) | Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52 | ||
Secondary | Safety assessed by the incidence and severity of adverse events | Up to 52 weeks after switching |
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