The Efficacy and Tolerance of Tacrolimus Sustained-releas... | NCT01309477

Studies
The Efficacy and Tolerance of Tacrolimus Sustained-release Capsules on Refractory Nephrotic Syndrome (RNS)

NCT01309477

Sponsor

Sun Yat-sen University

Status

Completed

Last Update Posted

Nov 2, 2011Estimated

Enrollment

20Estimated

Phase

Phase 3

Conditions

Nephrotic Syndrome

Interventions

Tacrolimus Sustained-release Capsules (ADVAGRAF)

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Feb 1, 2011

First Submission Date that Met QC Criteria

Mar 4, 2011

First Posted Date

Mar 7, 2011Estimated

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

Nov 1, 2011

Last Update Posted Date

Nov 2, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ADVAGRAF	Experimental	All subjects in the study will take the Tacrolimus Sustained-release Capsules (ADVAGRAF) orally at the basis of low dose prednisone treatment	Drug: Tacrolimus Sustained-release Capsules (ADVAGRAF)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus Sustained-release Capsules (ADVAGRAF)	Drug	Started: 0.05-0.1mg/kg/d, one time per day, then adjusting the dose to maintain the blood level 5-10ng/ml in the induction treatment .

Measure	Description	Time Frame
Remission rate (complete or partial remission) at 6 months		6 months after therapy

Measure	Description	Time Frame
relapse rate		every 3 months up to 6 months
side effects	infections, transient increases in serum creatinine, gastrointestinal complaints, liver function disorder and glucose intolerance , etc

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects of either sex, 14-60 years of age
Diagnosis of Nephrotic syndrome with hypoalbuminemia (< 3.0g/dl) and heavy proteinuria (> 3.5g/24hr) and exclude secondary Nephrotic syndrome
Refractory Nephrotic Syndrome
1. Steroid resistant: failure to respond (either complete or partial remission) after a course of 8 weeks of 1.0 mg/kg/d prednisone or equal dose of steroid therapy
2. Steroid dependent: recurrence of nephrotic proteinuria during tapering of prednisone at a dose > 10 mg/day or within the first 2 weeks after withdrawal of prednisone
3. Frequently recurrence: initial remission with steroid induction therapy, but relapsed 2 or more in 6 months or 3 or more within 12 months
4. Failure to respond (either complete or partial remission) even after CTX, MMF or CsA therapy combined with steroid
eGFR ≥ 60 ml/min/1.73 m2
Provision of written informed consent by subject or guardian

Exclusion Criteria:

Systemic disease
eGFR < 60ml/min/1.73m2
Diagnosed DM
Malignant tumors (except fully cured basal cell carcinoma)
Familial nephritic syndrome
History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease) within 3 month prior to enter this study
Any Active systemic infection or history of serious infection within one month of entry or known infection with HIV, hepatitis B, or hepatitis C
Known hypersensitivity or contraindication to tacrolimus, corticosteroids
Participation in another clinic trial and/or receipt of investigational drugs within 4 weeks prior to screening
Pregnancy, nursing or use of a non-reliable method of contraception
Inability or unwillingness to provide written informed consent
Usage of immunosuppression therapy (MMF, CTX, CysA, MTX ect) for more than 1 week within 1 month prior to first randomization or intravenous MP Pulse treatment

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

14 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009401	Nephrosis
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases