Tacrolimus Treatment of Patients With Idiopathic Membrano... | NCT00302523

Studies
Tacrolimus Treatment of Patients With Idiopathic Membranous Nephropathy

NCT00302523

Sponsor

Nanjing University School of Medicine

Status

Completed

Last Update Posted

Feb 3, 2012Estimated

Enrollment

16Actual

Phase

Not Applicable

Conditions

Idiopathic Membranous Nephropathy

Interventions

Tacrolimus

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

Feb 2012

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

Mar 2006

Primary Completion Date

Dec 2008Actual

Completion Date

Dec 2009Actual

First Submitted Date

Mar 13, 2006

First Submission Date that Met QC Criteria

Mar 13, 2006

First Posted Date

Mar 14, 2006Estimated

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

Feb 2, 2012

Last Update Posted Date

Feb 3, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zhi-Hong Liu, M.D., Research Institute of Nephrology, Nanjing University School of MedicinePrincipal Investigator

Lead Sponsor

Nanjing University School of MedicineOTHER

Collaborators

Not provided

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

Description Module

Brief Summary

The purpose of this study is:

To explore the potential role of tacrolimus in the treatment of membranous nephropathy.
To investigate the safety and tolerability of tacrolimus vs methylprednisolone plus cyclophosphamide.

Detailed Description

Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with Cyclosporine-A (CSA) in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a new calcineurin immunosuppressive drug, tacrolimus (FK506), in reducing the amount of protein in the urine in patients with membranous nephropathy. Forty patients with biopsy-proven membranous nephropathy will be recruited. Candidates must have completed at least six month of treatment with a stable dose of angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs). They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of tacrolimus in the treatment of membranous nephropathy. They will be treated with oral tacrolimus for 6 months, followed by 6 months of maintenance. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day. This study will explore the potential role of tacrolimus in the treatment of membranous nephropathy, which is usually resistant to conventional therapy.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FK506	Active Comparator		Drug: Tacrolimus

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Tacrolimus	Drug	FK506,0.1mg/kg/d	FK506	Tacrolimus,Prograf

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To explore the potential role of tacrolimus in the treatment of membranous nephropathy.		18 months

Secondary Outcomes

Measure	Description	Time Frame
To investigate the safety and tolerability of tacrolimus vs intravenous CTX pulse.		18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Biopsy-proven idiopathic membranous nephropathy
Nephrotic syndrome with proteinuria ( > 4 g/day) and serum albumin < 30 g/dl
Age 18-60 years with informed consent

Exclusion Criteria:

Patient with abnormal liver function tests
Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
Active/serious infection
Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
Patient who is diabetic
Patient is allergic or intolerant to macrolide antibiotics or tacrolimus

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhi-hong Liu, M.D.	Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine		Nanjing	Jiangsu	210002	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
34778952	Derived	von Groote TC, Williams G, Au EH, Chen Y, Mathew AT, Hodson EM, Tunnicliffe DJ. Immunosuppressive treatment for primary membranous nephropathy in adults with nephrotic syndrome. Cochrane Database Syst Rev. 2021 Nov 15;11(11):CD004293. doi: 10.1002/14651858.CD004293.pub4.

ID	Term
D005921	Glomerulonephritis
D009393	Nephritis
D007674	Kidney Diseases
D014570	Urologic Diseases

ID	Term
D018942	Macrolides
D007783	Lactones
D009930	Organic Chemicals