A Study of RC18 Administered Subcutaneously to Subjects With Primary IgA(Immunoglobulin A) Nephropathy

NCT04291781 | Completed Phase 2 DMC

• 1 other identifier: 18C014
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and efficacy of Tai Ai(Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in 24-hour urine protein excretion at Week 24;

  based on the 24 -hour urine collection

  week 24

Secondary Outcomes (10)

• Change from baseline in estimated Glomerular Filtration Rate(eGFR)

  week 0, 4, 8, 12, 16, 20, 24

• Change from baseline in urine protein/creatine ratio(UPCR) and/or urine albumin/ creatine ratio(UACR)

  week 0, 4, 8, 12, 16, 20, 24

• Change from baseline in Immunoglobulin G(IgG);

  week 0, 4, 8, 12, 16, 20, 24

• Change from baseline in Immunoglobulin M(IgM);

  week 0, 4, 8, 12, 16, 20, 24

• Change from baseline in Immunoglobulin A(IgA);

  week 0, 4, 8, 12, 16, 20, 24

Study Arms (3)

RC18 160mg

EXPERIMENTAL

RC18 160mg subcutaneous injection (S.C.) once weekly ,and a total of 24 doses

Biological: RC18 160mg

RC18 240mg

EXPERIMENTAL

RC18 240mg S.C. once weekly ,and a total of 24 doses

Biological: RC18 240mg

Placebo

PLACEBO COMPARATOR

Placebo S.C. once weekly ,and a total of 24 doses

Biological: placebo

Interventions

RC18 160mg BIOLOGICAL

subcutaneous injection on the upper arm, abdomen, or upper thigh outside;

Also known as: Tai Ai, Recombinant Human B-Lymphocyte Stimulator Receptor- Antibody Fusion Protein

RC18 160mg

RC18 240mg BIOLOGICAL

subcutaneous injection on the upper arm, abdomen, or upper thigh outside;

Also known as: Tai Ai, Recombinant Human B-Lymphocyte Stimulator Receptor- Antibody Fusion Protein

RC18 240mg

placebo BIOLOGICAL

subcutaneous injection on the upper arm, abdomen, or upper thigh outside;

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signing the informed consent;
• Biopsy confirmed diagnosis of IgA nephropathy;
• Male or female, between 18 and 70 years age;
• During screening, 24-hour urine protein excretion ≥0.75 g/24h at Visit 1 and/or Visit 2 and at Visit 3;
• Estimated glomerular filtration rate (eGFR) (CKD-EPI ) \>35 ml/min per 1.73m\^2;
• Have received the Angiotension converting enzyme Inhibitors(ACEI)/Angiotensin receptor blocker(ARB) standard treatment for 12 weeks prior to randomization, and have stabled the dosage (within the maximum tolerated dosage) for 4 weeks prior to randomization.

You may not qualify if:

• Abnormal laboratory tests;
• Any secondary IgA nephropathy caused by Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, sjogren syndrome, viral hepatitis, liver cirrhosis, rheumatoid arthritis, mixed connective tissue disease, polyarteritis nodosa, erythema nodosum, psoriasis, ulcerative colitis, crohn\'s disease, tumor, AIDS ,etc.;
• Any nephropathy with special pathologic or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis(with \>50% of biopsied glomeruli), minimal change disease with IgA deposition; and IgA nephropathy requiring corticosteroids treatment.
• Suffering from cardiovascular and cerebrovascular events (myocardial infarction, unstable angina, ventricular arrhythmia, New York heart association grade III-IV heart failure, stroke, etc.) within the last 12 weeks;
• Treating with systemic corticosteroids drug(excluding topical or nasal steroids) within 3 months prior to randomizing;
• Treating with systemic immunosuppressor within 3 months prior to randomizing: cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, tripterygium wilfordii, etc.;
• Requiring hospitalization or intravenous antibiotics treatment due to active infection within 3 months prior to randomizing;
• Active tuberculosis or latent carrier without treatment;
• Herpes zoster infected patients or patients with positive HIV antibody or positive HCV antibody;
• Active hepatitis or severe liver disease, and HBV infection (According to the HBV screening test, ① the HBsAg-positive; ②HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.)
• With malignant tumors;
• Pregnancy ，lactation, or patients with childbearing plans during the trial;
• Nephrotoxic drugs is unavoidable during the study period;
• Allergy to human-derived biologics;
• Receiving any other investigating drug 4 weeks or 5 times half-life of the experimental drug (whichever is longer) prior to randomization;

Sponsors & Collaborators

• RemeGen Co., Ltd.: lead

Study Sites (1)

Peking University First Hospital.

Beijing, Beijing Municipality, 100010, 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: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Interventions

RC-18

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

Study Officials

• Hong Zhang, M.D.

  Peking University First Hospital

  PRINCIPAL INVESTIGATOR

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: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2020
• First Posted: March 2, 2020
• Study Start: April 13, 2020
• Primary Completion: May 20, 2021
• Study Completion: May 20, 2021
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)