Low-dose Combination of Mycophenolate Mofetil (MMF) and T... | NCT01203709

Studies
Low-dose Combination of Mycophenolate Mofetil (MMF) and Tacrolimus (Tac) for Refractory Lupus Nephritis

NCT01203709

Sponsor

Tuen Mun Hospital

Status

Completed

Last Update Posted

Mar 4, 2014Estimated

Enrollment

20Actual

Phase

Phase 4

Conditions

Lupus Nephritis

Interventions

low dose combination of MMF and Tac

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

Mar 2014

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

Aug 2010

Primary Completion Date

Dec 2012Actual

Completion Date

Feb 2013Actual

First Submitted Date

Sep 15, 2010

First Submission Date that Met QC Criteria

Sep 15, 2010

First Posted Date

Sep 16, 2010Estimated

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

Mar 3, 2014

Last Update Posted Date

Mar 4, 2014Estimated

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

A trial of combination of two drugs for the treatment of refractory lupus nephritis.

Detailed Description

Low-dose combination of mycophenolate mofetil and tacrolimus for refractory lupus nephritis: a 12-month prospective study

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Combination treatment	Experimental	treatment arm	Drug: low dose combination of MMF and Tac

Interventions

Name	Type	Description	Arm Group Labels	Other Names
low dose combination of MMF and Tac	Drug	mycophenolate mofetil 500mg BID + tacrolimus 2mg BID	Combination treatment

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical remission rate		12 months

Secondary Outcomes

Measure	Description	Time Frame
Adverse events	adverse events experienced by patients as a measure of tolerability	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Active nephritis documented by renal biopsy within 24 months of entry;
Failure to respond to 2 or more immunosuppressive regimens which consisted of high-dose prednisolone combined with other non-corticosteroid immunosuppressive agents together with ACE inhibitors plus or minus angiotensin receptor blockers (ARB) for at least 4 months for each regimen at the maximally tolerated drug dosages;
Serum creatinine (Scr) less than 200umol/L.

Exclusion Criteria:

Previous intolerance to either MMF/Tac;
Scr >200umol/L;
Informed consent unavailable.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
CC Mok, MD, FRCP	Tuen Mun Hospital, Hong Kong China	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tuen Mun Hospital		Hong Kong			China

Condition Browse Module

MeSH Terms

ID	Term
D008181	Lupus Nephritis
D009393	Nephritis
D005921	Glomerulonephritis
D007674	Kidney Diseases

Ancestor Terms

ID	Term
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014221	Triamcinolone
D009173	Mycophenolic Acid
D016559	Tacrolimus

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided