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

Lupus Nephritis Clinical Trial

— LuFla  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02313974
• Other study ID #: HSM LuNe
• Status: Active, not recruiting
• Phase: N/A
• First received: December 8, 2014
• Last updated: September 12, 2016
• Start date: January 2014
• Est. completion date: November 2018

Study information

• Verified date: September 2016
• Source: Hospital de Clinicas José de San Martín
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Institute for Clinical Effectiveness and Health Policy
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: November 2018
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus Nephritis
• Nephritis

Intervention

Procedure:
• Renal Biopsy

Locations

Country	Name	City	State
Argentina	Hospital de Clinicas	Buenos Aires	Caba

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas José de San Martín

Country where clinical trial is conducted

Argentina, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Renal Flares	Renal relapse after a complete treatment in complete remission patients	2 years	No