NCT02942381

A Study of Hydroxychloroquine Sulfate for Reduction of Proteinuria in Patients With IgA Nephropathy

Completed Phase 2 Last updated 5 February 2018

What this trial tests

Phase 2 trial testing Hydroxychloroquine Sulfate in IgA Patients in 60 participants. Completed in 8 January 2018.

Timeline

13 September 2016

Primary endpoint
8 January 2018

8 January 2018

Quick facts

Lead sponsor	Peking University First Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	60
Start date	13 September 2016
Primary completion	8 January 2018
Estimated completion	8 January 2018
Sites	1 location across China

Drugs / interventions tested

• Hydroxychloroquine Sulfate (hydroxychloroquine-pill) — full drug profile →
• Placebo

Conditions studied

• IgA Patients — all drugs for IgA Patients →
• Hydroxychloroquine — all drugs for Hydroxychloroquine →

Sponsor

Peking University First Hospital

Who can join

Adults 18 to 75, any sex, with IgA Patients or Hydroxychloroquine. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. IgA Nephropathy: An Interesting Autoimmune Kidney Disease.
   Rajasekaran A, Julian BA, Rizk DV. · · 2021 · cited 164× · PMID 33309134 · DOI 10.1016/j.amjms.2020.10.003
2. Effects of Hydroxychloroquine on Proteinuria in IgA Nephropathy: A Randomized Controlled Trial.
   Liu LJ, Yang YZ, Shi SF, Bao YF, et al · · 2019 · cited 141× · PMID 30922594 · DOI 10.1053/j.ajkd.2019.01.026
3. An Update on the Current State of Management and Clinical Trials for IgA Nephropathy.
   Cheung CK, Rajasekaran A, Barratt J, Rizk DV. · · 2021 · cited 41× · PMID 34200024 · DOI 10.3390/jcm10112493
4. Comparison of the effects of hydroxychloroquine and corticosteroid treatment on proteinuria in IgA nephropathy: a case-control study.
   Yang YZ, Chen P, Liu LJ, Cai QQ, et al · · 2019 · cited 32× · PMID 31382914 · DOI 10.1186/s12882-019-1488-6
5. IgA Nephropathy: Current Understanding and Perspectives on Pathogenesis and Targeted Treatment.
   Du Y, Cheng T, Liu C, Zhu T, et al · · 2023 · cited 31× · PMID 36673113 · DOI 10.3390/diagnostics13020303
6. IgA Nephropathy: A Chinese Perspective.
   Zhang Z, Zhang Y, Zhang H. · · 2022 · cited 16× · PMID 36751266 · DOI 10.1159/000520039
7. IgA Nephropathy: An Overview of the Clinical Trials.
   Gholizadeh Ghozloujeh Z, Selvaskandan H, Wiegley N, Lerma E, et al · · 2025 · cited 3× · PMID 41050133 · DOI 10.1016/j.xkme.2025.101078
8. Finerenone and other future therapeutic options for Alport syndrome.
   Pearce H, Mabillard H. · · 2023 · cited 3× · PMID 39429698 · DOI 10.1007/s44162-023-00022-x