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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02268201
Other study ID # ACNKTxCon
Secondary ID
Status Terminated
Phase Phase 4
First received
Last updated
Start date July 23, 2013
Est. completion date March 31, 2015

Study information

Verified date January 2019
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

The primary objective of this study is to compare the adherence of kidney transplant recipients treated with Prograf and Advagraf regimens.

The secondary objectives of this study are:

- To compare the renal function (eGFR) in KTx recipients treated with Cyclosporine and Tacrolimus regimens.

- To compare the QoL of KTx recipients treated with Cyclosporine and Tacrolimus regimens.

- To compare the efficacy of Cyclosporine and Tacrolimus regimens in KTx recipients.

- To compare the safety of Cyclosporine and Tacrolimus regimens in KTx recipients.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Advagraf
oral
Prograf
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 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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