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

September 12, 2016 updated by: Marcelo A De Rosa, MD, Hospital de Clinicas José de San Martín

Lupus Flares and Histological Renal Activity at the End of the Treatment

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

36

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Caba
      • Buenos Aires, Caba, Argentina, 1120
        • Hospital de Clínicas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Proliferative Lupus Nephritis confirmed by renal biopsy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital de Clinicas José de San Martín

Investigators

  • Principal Investigator: Marcelo A De Rosa, Physician, Hospital de Clinicas. UBA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Anticipated)

November 1, 2016

Study Completion (Anticipated)

November 1, 2018

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSM LuNe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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