A Study to Evaluate the Efficacy and Safety in Kidney Tra... | NCT02268201

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Due to difficulty enrolling patients

Expanded Access Info

Start Date

Jul 23, 2013Actual

Primary Completion Date

Mar 31, 2015Actual

Completion Date

Mar 31, 2015Actual

First Submitted Date

Oct 15, 2014

First Submission Date that Met QC Criteria

Oct 15, 2014

First Posted Date

Oct 20, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 30, 2024

Last Update Posted Date

Nov 1, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

17Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADV group	Experimental	Once daily	Drug: Advagraf
PRG group	Experimental	Twice daily	Drug: Prograf

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Advagraf	Drug	oral	ADV group	Tacrolimus prolonged-release capsule

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Director	Astellas Pharma Inc	Study Director

Label	URL
Link to results on the Astellas Clinical Study Results website	View source

IPD Sharing Statement Module

Plan to Share IPD

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/.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Beijing			China

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals