Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy: a Self- Controlled Study

NCT02351752 | Completed Phase 4

• 1 other identifier: 2014【851】
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

IgA nephropathy is the most common type of primary glomerulonephritis and might caused by deposition of immune complex containing IgA in mesangium and causing local immune activation. Hydroxychloroquine reduces the activation of dendritic cells and the inflammatory process and showed the potential effect of treatment of patients with IgA nephropathy. The investigators study will recruite IgA nephropathy patients with proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB. The patients were treated with Hydroxychloroquine 300-400mg/d according to eGFR. The proteinuria will recorded every two months and total four months. Then, the drug will be stopped for two months for observation of change of proteinuria.

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• proteinuia

  total four months(proteinic will recorded every 2 months )

Study Arms (1)

Hydroxychloroquine Sulfate

EXPERIMENTAL

Hydroxychloroquine Sulfate 0.1 Tid (eGFR 30-59), 0.2 Bid(eGFR \>60)

Drug: Hydroxychloroquine Sulfate

Interventions

Hydroxychloroquine Sulfate DRUG

Hydroxychloroquine Sulfate: 0.1 Tid(eGFR 30-59);0.2 Bid (eGFR\>60)

Hydroxychloroquine Sulfate

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• primary IgA nephopathy
• age 18-75 years
• proteinuria range from 0.75 to 3.5g/d even after three-month treatment by sufficient ACEi/ARB
• eGFR\>30ml/min/1.73m2

You may not qualify if:

• immune suppressive agent in recent one years
• crescent glomerulonephritis, might use immune suppressive agent
• chronic hepatic disease
• myocardial infarction
• malignant hypertension
• stroke
• malignant tumor
• retinopathy
• other contraindication of Hydroxychloroquine
• pregnancy and breastfeeding women
• life expectancy for less than 6 months
• in other clinical trials
• not suitable for the study judged by investigator

Sponsors & Collaborators

• LLiu: lead

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

Hydroxychloroquine

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Hong Zhang, PhD,MD

  Peking University First Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Renal Division, Peking University First Hospital

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: January 1, 2015
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: December 17, 2015

Record last verified: 2015-12

Locations

CN (1)