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

NCT02313974 | Unknown DMC

• 1 other identifier: HSM LuNe
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Lupus Nephritis

Keywords

Lupus Nephritis Treatment; Renal Biopsy in Lupus; Lupus Flare

Outcome Measures

Primary Outcomes (1)

• Renal Flares

  Renal relapse after a complete treatment in complete remission patients

  2 years

Interventions

Renal Biopsy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with Proliferative Lupus Nephritis confirmed by renal biopsy

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Hospital de Clinicas José de San Martín: lead

Study Sites (1)

Hospital de Clinicas

Buenos Aires, Buenos Aires F.D., 1120, Argentina

Location

Related Publications (1)

• 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.

  PMID: 30045812 DERIVED

MeSH Terms

Conditions

Lupus Nephritis

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marcelo A De Rosa, Physician

  Hospital de Clinicas. UBA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: January 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2018
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

AR (1)