NCT04525729

Brief Summary

A study to evaluate safety and activity in treatment of IgAN patients using Rituximab in combination with RASi(ACEI and/or ARB) compared with RASi.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jul 2020

Longer than P75 for phase_4

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

July 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 17, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 25, 2020

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

3.7 years

First QC Date

August 17, 2020

Last Update Submit

March 12, 2025

Conditions

IgA Nephropathy

Keywords

IgANRituximabRASiGd-IgA1proteinuria

Outcome Measures

Primary Outcomes (1)

  • Changes in proteinuria levels over 1 year compared with baseline

    Primary outcome included changes in proteinuria levels over 1 year compared with baseline

    1 year

Secondary Outcomes (9)

  • The proportion of 50% reduction in mean urinary protein compared with baseline over 1 year

    1 year

  • The proportion of 50% reduction in mean urinary protein compared with baseline over 6 months

    6 months

  • Changes in proteinuria levels over 6 months compared with baseline

    6 months

  • Changes in eGFR levels over 1 year compared with baseline

    1 year

  • Changes in Gd-IgA1 levels

    1 year

  • +4 more secondary outcomes

Study Arms (2)

Rituximab+RASi(ACEI and/or ARB)

EXPERIMENTAL

The maximum tolerable dose of RASi will be using everyday depending on the individual factors of the subject, combined with rituximab 1g(D1, D31 respectively, intravenous infusion). Add 1 g rituximab at 6 months.

Drug: RituximabDrug: RAS 2410

RASi(ACEI and/or ARB）

OTHER

The maximum tolerable dose of RASi will be using everyday depending on the individual factors of the subject.

Drug: RAS 2410

Interventions

RituximabDRUG

To evaluate the efficacy and safety of HLX01 combined with RASi in patients with IgAN.

Also known as: HLX01
Rituximab+RASi(ACEI and/or ARB)
RAS 2410DRUG

To evaluate the efficacy and safety of RASi in patients with IgAN.

Also known as: No specific restrictions
RASi(ACEI and/or ARB）Rituximab+RASi(ACEI and/or ARB)

Eligibility Criteria

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

You may qualify if:

  • \. 18 to 75 of age, male or female;
  • \. primary IgA nephropathy confirmed by renal biopsy
  • \. eGFR\>30ml/min/1.73m2(calculated according to the CKD-EPI formula);
  • \. After using maximum tolerated doses of ACEI and/or ARB for 3 months, the following two points should be met:
  • h proteinuria ≥1g;
  • Bp\<130/80 mmHg；
  • \. Serum albumin \> 25g/L;
  • \. Sign the informed consent.
  • Note : It is suggested that active IgAN patients should be selected. Active IgAN is specifically defined as conforming to any of the following :
  • ) intradermal augmentation ( E1 ),
  • ) crescentic body 0 - 50 % ( C1 / C2 ),
  • ) fibrinoid necrosis,
  • ) more interstitial inflammatory cell infiltration. At the same time, the proportion of sclerosis was low ( spherical or segmental sclerosis ball \< 50 % ), and interstitial fibrosis was low ( below T2 ).

You may not qualify if:

  • \. Evidence of the use of glucocorticoids for immunosuppressive therapy, such as: nephrotic syndrome, pathology for small lesions with IgA nephropathy. or the proportion of crescents confirmed by renal biopsy within 12 months was more than 50 %.
  • \. Clinical confirmation of cirrhosis, chronic active liver disease, or hepatitis B, C, or HIV which can detect viral replication;
  • \. Clinically confirmed IgA nephropathy secondary to systemic diseases such as systemic lupus erythematosus, allergic purpura.
  • \. Patients with non-simple IgA nephropathy, such as diabetic nephropathy or obesity-related nephropathy.
  • \. A history of active systemic infection or severe infection occurred one month before enrollment.
  • \. Those who are pregnant or lactating or unwilling to take contraceptive measures.
  • \. Current or recent ( within 30 days ) exposure to any research drug.
  • \. Patients with allergic reactions to rituximab and / or known allergic reactions.
  • \. Laboratory tests meeting the following criteria should be excluded:
  • (1) Hemoglobin \<80g/L; (2) Platelet \<80×10\^9/L; (3) Neutrophils \< 1.0×10\^9/L; (4) Aspartic acid aminotransferase (AST) or alanine aminotransferase (ALT) \>2.5× normal upper limit, except for the correlation with the primary disease;
  • \. Continuous use of hormones or other immunosuppressive therapy in the past 6 months;
  • \. Accompanying or past malignant tumors, except for fully treated skin basal or squamous cell carcinoma or cervical carcinoma in situ;
  • \. History of psychosis may interfere with normal participation in this study;
  • \. Patients with major heart or lung diseases (including obstructive pulmonary disease);
  • \. In acute and chronic tuberculosis infection period (tuberculin test positive, chest X-ray suspected tuberculosis patients);
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital, Shanghai JiaoTong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

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: 38299639DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGAProteinuria

Interventions

Rituximabresminostat

Condition Hierarchy (Ancestors)

GlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System DiseasesUrination DisordersUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-DerivedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Jingyuan Xie

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 17, 2020

First Posted

August 25, 2020

Study Start

July 1, 2020

Primary Completion

March 30, 2024

Study Completion

March 30, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Locations

CN(1)