Lupus Flares and Histological Renal Activity at the End o... | NCT02313974

Studies
Lupus Flares and Histological Renal Activity at the End of the Treatment (LuFla)

NCT02313974

Sponsor

Hospital de Clinicas José de San Martín

Status

Unknown status

Last Update Posted

Sep 14, 2016Estimated

Enrollment

36Actual

Phase

Not provided

Conditions

Lupus Nephritis

Interventions

Renal Biopsy

Countries

Argentina

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

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Nov 2016Estimated

Completion Date

Nov 2018Estimated

First Submitted Date

Dec 8, 2014

First Submission Date that Met QC Criteria

Dec 9, 2014

First Posted Date

Dec 10, 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

Sep 12, 2016

Last Update Posted Date

Sep 14, 2016Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Marcelo A De Rosa, MD, Physician, Hospital de Clinicas José de San MartínPrincipal Investigator

Lead Sponsor

Hospital de Clinicas José de San MartínOTHER

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

At this moment, the duration of the treatment in Proliferative Lupus Nephritis has not been determined.

Almost 30 percent of patients in total remission during or after a treatment, will relapse in the first 5 years.

The factors associated to Renal relapses are not completly known. The investigators think that an histological control study performed to patient with complete remission for a year at the end of a 3 years treatment could help us to know which patients are going to relapse.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Name	Type	Description	Arm Group Labels	Other Names
Renal Biopsy	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Renal Flares	Renal relapse after a complete treatment in complete remission patients	2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria :

Patients between 18 and 70 years old with Proliferative Lupus Nephritis
3 years treatment with a 6 month induction therapy and 2 years and a half of treatment maintenence

Exclusion Criteria :

Membranous Nephropaty
Mesangial Nephropathy
Less than 3 years treatment
Less than 1 year of complete remission

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with Proliferative Lupus Nephritis confirmed by renal biopsy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Marcelo A De Rosa, Physician	Hospital de Clinicas. UBA	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Clinicas		Buenos Aires	Buenos Aires F.D.	1120	Argentina

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30045812	Derived	De Rosa M, Azzato F, Toblli JE, De Rosa G, Fuentes F, Nagaraja HN, Nash R, Rovin BH. A prospective observational cohort study highlights kidney biopsy findings of lupus nephritis patients in remission who flare following withdrawal of maintenance therapy. Kidney Int. 2018 Oct;94(4):788-794. doi: 10.1016/j.kint.2018.05.021. Epub 2018 Jul 23.

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