NCT02942381

Brief Summary

The investigators study will recruit 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 200-400mg/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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 13, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 14, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 24, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

1.3 years

First QC Date

October 14, 2016

Last Update Submit

February 2, 2018

Conditions

IgA PatientsHydroxychloroquine

Outcome Measures

Primary Outcomes (1)

  • Proteinuria （g/d）

    every two months(total six months)

Secondary Outcomes (1)

  • Albuminuria and creatinine ratio(mg/g)

    every two months(total six months)

Study Arms (2)

Hydroxychloroquine Sulfate

ACTIVE COMPARATOR

200mg Bid (eGFR\>60 ml/min/1.73m2), 100mg Tid (eGFR45-59 ml/min/1.73m2), 100mg Bid (eGFR 30-44 ml/min/1.73m2) and supportive treatment

Drug: Hydroxychloroquine Sulfate

Placebo

PLACEBO COMPARATOR

Placebo and supportive treatment

Drug: Placebo

Interventions

Hydroxychloroquine SulfateDRUG

200mg Bid (eGFR\>60 ml/min/1.73m2 ), 100mg Tid(eGFR45-59 ml/min/1.73m2 ), 100mg Bid(eGFR 30-44 ml/min/1.73m2 )

Hydroxychloroquine Sulfate
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary IgA nephropathy
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

Related Publications (2)

  • Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

    PMID: 38299639DERIVED

  • Liu LJ, Yang YZ, Shi SF, Bao YF, Yang C, Zhu SN, Sui GL, Chen YQ, Lv JC, Zhang H. Effects of Hydroxychloroquine on Proteinuria in IgA Nephropathy: A Randomized Controlled Trial. Am J Kidney Dis. 2019 Jul;74(1):15-22. doi: 10.1053/j.ajkd.2019.01.026. Epub 2019 Mar 25.

    PMID: 30922594DERIVED

MeSH Terms

Interventions

Hydroxychloroquine

Intervention Hierarchy (Ancestors)

ChloroquineAminoquinolinesQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Peking University First Hospital Research department

Study Record Dates

First Submitted

October 14, 2016

First Posted

October 24, 2016

Study Start

September 13, 2016

Primary Completion

January 8, 2018

Study Completion

January 8, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Locations

CN(1)