A Study to Evaluate the Efficacy and Safety in Kidney Transplant Recipients When Changed From Cyclosporine to Tacrolimus Prolonged-release Capsule or Tacrolimus Capsule

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02268201
• Other study ID #: ACNKTxCon
• Status: Terminated
• Phase: Phase 4
• 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
• 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

Related Conditions & MeSH terms

• Kidney Transplant Recipients

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

External Links

•   Link to results on the Astellas Clinical Study Results website