Hydroxychloroquine Sulfate Alleviates Persistent Proteinuria in IgA Nephropathy

NCT02765594 | Unknown Phase 4 DMC

• 1 other identifier: PUMCHHCQIgAN01
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

Immunoglobulin A nephropathy (IgAN) is the most common primary glomerulonephritis in the world.There is to date no curative therapy for patients with IgAN.It is considered that dendritic cells, Toll-like receptor (TLR) 9 and cytokines interleukin-6 (IL-6), and interferon-alpha (IFN-a) and tumor necrosis factor-alpha (TNF-α), play an important role in the aberrant mucosal response. Hydroxychloroquine is an antimalarial agent and had a notable impact on immune activation by the reduction of circulating activated immune cells that including decreased TLR-expressing cells, reduced IFN-secreting plasmacytoid dendritic cells, reduced production of inflammatory cytokines including interferon alpha, IL-6 and TNF alpha. Recent studies showed hydroxychloroquine had a benefit for renal remission and could retard the onset of renal damage in patients with lupus nephritis. hydroxychloroquine may have the potential effect in IgA nephropathy, alleviated the proteinuria and had the renal protect effect. This will be a single center, prospective, randomized, controlled study to assess the utility of hydroxychloroquine in IgAN patients.

Conditions

Primary IgA Nephropathy

Keywords

Glomerulonephritis, IGA; Kidney Diseases; Autoimmune Diseases; Glomerulonephritis; Nephritis; Immune System Diseases; Urologic Diseases; Hydroxychloroquine; Anti-Infective Agents; Antimalarials; Antiparasitic Agents; Antiprotozoal Agents; Antirheumatic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Therapeutic Uses; interleukin-6; interferon-alpha; tumor necrosis factor-alpha

Outcome Measures

Primary Outcomes (1)

• Incidence of Remission (Complete [CR] or Partial [PR]) at Week 24

  CR: proteinuria \<0.3 g/24 hr with no worsening of renal function (\<15% estimated glomerular filtration rate(eGFR) reduction from Baseline).PR: proteinuria \<3.5g/24 hrs but ≥0.3g/24 hrs and a decrease of \>50% from Baseline based on 24 hours pooled urine, with no worsening of renal function(\<15% eGFR reduction from Baseline). eGFR at Baseline will be defined as the Day 0 values.

  24 weeks

Secondary Outcomes (8)

• Change from Baseline in Proteinuria Levels at the Indicated Time Points

  Baseline and Weeks 4, 12, 24

• Change from Baseline in Serum Creatinine Levels at the Indicated Time Points

  Baseline and Weeks 4, 12, 24

• Change from Baseline in eGFR at the Indicated Time Points

  Baseline and Weeks 4, 12, 24

• Change from Baseline in Serum IgA Levels at the Indicated Time Points

  Baseline and Weeks 4, 12, 24

• Change from Baseline in Serum Interleukin-6 Levels at the Indicated Time Points

  Baseline and Weeks 4, 12, 24

Study Arms (2)

valsartan only:control group

EXPERIMENTAL

valsartan (160mg/d)

Drug: Valsartan

hydroxychloroquine with valsartan:study group

EXPERIMENTAL

valsartan (160mg/d) and Hydroxychloroquine Sulfate ( 400mg/d, twice daily)

Drug: Hydroxychloroquine Sulfate; Drug: Valsartan

Interventions

Hydroxychloroquine Sulfate DRUG

200mg bid

Also known as: Fenle

hydroxychloroquine with valsartan:study group

Valsartan DRUG

160mg qd

Also known as: Diovan

hydroxychloroquine with valsartan:study group; valsartan only:control group

Eligibility Criteria

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

You may qualify if:

• biopsy proven primary IgA nephropathy
• age 18-60 years
• proteinuria range from 0.5 to 1.5g/d
• serum creatinine ≤132.6μmol/L
• normal blood pressure or blood pressure ≤130/80 mmHg in patients with hypertension

You may not qualify if:

• Hypersensitivity to chloroquine or to hydroxychloroquine
• blood pressure \<90/60 mm Hg
• pregnancy and breastfeeding women
• renal artery stenosis
• Rapidly progressive renal insufficiency
• systemic lupus erythematosus or other connective tissue diseases
• Henoch- schoenlein purpura
• other nephritis
• diabetes mellitus
• retinopathy
• other contraindication of hydroxychloroquine
• severe hepatic insufficiency
• G6PD deficiency
• psoriasis or porphyria
• malignant hypertension

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peing Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Related Publications (1)

• 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: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases; Autoimmune Diseases; Glomerulonephritis; Nephritis; Immune System Diseases; Urologic Diseases

Interventions

Hydroxychloroquine; Valsartan

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• RUITONG GAO, MD

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

RUITONG GAO, MD

CONTACT

86-010-69155058; gaoruitong@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2016
• First Posted: May 6, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2019
• Study Completion: June 1, 2019
• Last Updated: September 20, 2017

Record last verified: 2017-09

Locations

CN (1)