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

Sponsor

Astellas Pharma China, Inc. (Industry)

Overall Status

Terminated

CT.gov ID

NCT02268201

Collaborator

(none)

Enrollment

Locations

Arms

20.2

Actual Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplant Recipients	Drug: Advagraf Drug: Prograf	Phase 4

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 23, 2013

Actual Primary Completion Date :

Mar 31, 2015

Actual Study Completion Date :

Mar 31, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ADV group Once daily	Drug: Advagraf oral Other Names: Tacrolimus prolonged-release capsule
Experimental: PRG group Twice daily	Drug: Prograf oral Other Names: Tacrolimus capsule

Arm

Intervention/Treatment

Experimental: ADV group

Once daily

Drug: Advagraf

oral

Other Names:

Tacrolimus prolonged-release capsule

Experimental: PRG group

Twice daily

Drug: Prograf

oral

Other Names:

Tacrolimus capsule

Outcome Measures

Primary Outcome Measures

medication adherence [Up to 52 weeks after switching]
VAS will be used to evaluate adherence between PRG and ADV

Secondary Outcome Measures

endogenous creatinine clearance rate (Ccr) [Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52]
Calculated glomerular filtration rate [Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52]
blood lipids [Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52]
total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol and triglyceride
liver function (AST, ALT and bilirubin) [Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52]
fasting blood-glucose (FBG) [Day 0, Week-1, Week2, Week-4, Week-8, Week-16, Week-24, Week36 and Week-52]
Safety assessed by the incidence and severity of adverse events [Up to 52 weeks after switching]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	City	Country
1	Beijing	China
2	Fuzhou	China
3	Guangzhou	China
4	Jinan	China
5	Nanchang	China
6	Shanghai	China
7	Xi'an	China

Sponsors and Collaborators

Astellas Pharma China, Inc.

Investigators

Study Director: Medical Director, Astellas Pharma Inc

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Link to results on the Astellas Clinical Study Results website

Publications

None provided.

Responsible Party:

Astellas Pharma China, Inc.

ClinicalTrials.gov Identifier:

NCT02268201

Other Study ID Numbers:

ACNKTxCon

First Posted:

Oct 20, 2014

Last Update Posted:

Feb 1, 2019

Last Verified:

Jan 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Astellas Pharma China, Inc.

tacrolimus

immunosuppressive therapy

Additional relevant MeSH terms:

Tacrolimus

Study Results

No Results Posted as of Feb 1, 2019