Efficiency of Use of Baracetinib in Treatment of Lupus Nephritis

NCT05432531 | Unknown Phase 3 DMC

• 1 other identifier: Baracetinib
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with systemic lupus erythematosus have substantial unmet medical need. Baricitinib is an oral selective Janus kinase (JAK)1 and JAK2 inhibitor that we hypothesised might have therapeutic benefit in patients with systemic lupus erythematosus and had a diagnosis of systemic lupus erythematosus, and had active renal disease as defined by Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K). Efficacy and safety analyses included all patients who received at least one dose of study drug.

Conditions

Lupus Nephritis

Outcome Measures

Primary Outcomes (1)

• Album in urine

  24 h protein in urine

  6 months

Secondary Outcomes (3)

• complement 3

  3 and 6 months

• anti double strand DNA

  3 and 6 months

• lupus activity index-2K

  3 and 6 months

Study Arms (2)

Baracetinib

EXPERIMENTAL

oral tablet 4 mg baricitinib and placebo IV infusion/ month

Drug: Anti JAK1,2

Cyclophosphamide

ACTIVE COMPARATOR

IV cyclophosphamide 0.7mg/m2 every month and placebo tablet daily

Drug: Cyclophosphamid

Interventions

Anti JAK1,2 DRUG

Induction of remission of active lupus nephritis

Also known as: Baritava

Baracetinib

Cyclophosphamid DRUG

Induction of remission of active lupus nephritis

Also known as: Indoxan

Cyclophosphamide

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• lupus nephritis

You may not qualify if:

• cardiac disease Thrombosis

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Manal Hassanien

Asyut, Assuit, 71111, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

Cyclophosphamide

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

Intervention Hierarchy (Ancestors)

Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Study Officials

• Manal M Hassanien, Md

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: patient and outcome assessor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: June 1, 2022
• Primary Completion: December 31, 2022
• Study Completion: April 1, 2023
• Last Updated: January 4, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)