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

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

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.

Study Overview

• Status: Terminated
• Conditions: Kidney Transplant Recipients
• Intervention / Treatment: Drug: Prograf; Drug: Advagraf

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 Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Beijing, China
  • Fuzhou, China
  • Guangzhou, China
  • Jinan, China
  • Nanchang, China
  • Shanghai, China
  • Xi'an, China

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
medication adherence	VAS will be used to evaluate adherence between PRG and ADV	Up to 52 weeks after switching

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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
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

Collaborators and Investigators

• Sponsor: Astellas Pharma China, Inc.
• Investigators: Study Director: Medical Director, Astellas Pharma Inc

Publications and helpful links

Helpful Links

• Link to results on the Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2013
• Primary Completion (Actual): March 31, 2015
• Study Completion (Actual): March 31, 2015

Study Registration Dates

• First Submitted: October 15, 2014
• First Submitted That Met QC Criteria: October 15, 2014
• First Posted (Estimated): October 20, 2014

Study Record Updates

• Last Update Posted (Actual): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: tacrolimus; immunosuppressive therapy
• Additional Relevant MeSH Terms: Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Calcineurin Inhibitors; Tacrolimus
• Other Study ID Numbers: ACNKTxCon

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.