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CompletedNCT04291781Updated Sep 19, 2024

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

A Phase 2 interventional study of RC18 160mg and RC18 240mg in Primary IgA Nephropathy, sponsored by RemeGen Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by RemeGen Co., Ltd. · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the detailed description

Both RC18 and Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection are other names of Tai Ai.

After a 35-day screen period, subjects are randomly allocated into 3 groups receiving subcutaneous injection of Tai Ai 160mg, Tai Ai 240mg, and placebo once a week individually. The treatment lasts 24 weeks. Subjects, the sponsor, investigators are blinded in the whole process of the trial.

02

Conditions studied

  • Primary IgA Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 44 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

RemeGen Co., Ltd. is the lead sponsor of 77 studies on the registry; 37 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signing the informed consent;
  2. Biopsy confirmed diagnosis of IgA nephropathy;
  3. Male or female, between 18 and 70 years age;
  4. During screening, 24-hour urine protein excretion ≥0.75 g/24h at Visit 1 and/or Visit 2 and at Visit 3;
  5. Estimated glomerular filtration rate (eGFR) (CKD-EPI ) >35 ml/min per 1.73m\^2;
  6. 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.

Exclusion criteria

Exclusion Criteria:

  1. Abnormal laboratory tests;
  2. 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.;
  3. 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.
  4. 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;
  5. Treating with systemic corticosteroids drug(excluding topical or nasal steroids) within 3 months prior to randomizing;
  6. Treating with systemic immunosuppressor within 3 months prior to randomizing: cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, tripterygium wilfordii, etc.;
  7. Requiring hospitalization or intravenous antibiotics treatment due to active infection within 3 months prior to randomizing;
  8. Active tuberculosis or latent carrier without treatment;
  9. Herpes zoster infected patients or patients with positive HIV antibody or positive HCV antibody;
  10. 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.)
  11. With malignant tumors;
  12. Pregnancy ,lactation, or patients with childbearing plans during the trial;
  13. Nephrotoxic drugs is unavoidable during the study period;
  14. Allergy to human-derived biologics;
  15. Receiving any other investigating drug 4 weeks or 5 times half-life of the experimental drug (whichever is longer) prior to randomization;
  16. Not suitable for the study judged by investigator.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (actual)

Study arms

  • Experimental
    RC18 160mg

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

    Biological: RC18 160mg

  • Experimental
    RC18 240mg

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

    Biological: RC18 240mg

  • Placebo comparator
    Placebo

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

    Biological: placebo

Interventions

  • BiologicalRC18 160mg

    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

  • BiologicalRC18 240mg

    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

  • Biologicalplacebo

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

06

What researchers measure

Primary outcomes

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

    based on the 24 -hour urine collection

    Time frame: week 24

Secondary outcomes

  1. Change from baseline in estimated Glomerular Filtration Rate(eGFR)

    eGFR is calculated using the CKD-EPI method.

    Time frame: week 0, 4, 8, 12, 16, 20, 24

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

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  3. Change from baseline in Immunoglobulin G(IgG);

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  4. Change from baseline in Immunoglobulin M(IgM);

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  5. Change from baseline in Immunoglobulin A(IgA);

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  6. Change from baseline in the count of urine red blood cells

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  7. Change from baseline in the count of B-lymphocytes (CD19+)

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  8. Change from baseline in complement 3(C3)

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  9. Change from baseline in complement 4 (C4)

    Time frame: week 0, 4, 8, 12, 16, 20, 24

  10. The incidence rate and severity of adverse events.

    An adverse event is any undesirable experience associated with the use of a medical product in a patient.

    Time frame: week 0, 4, 8, 12, 16, 20, 24

07

Study locations

1 site
  • Peking University First Hospital.
    Beijing, Beijing 100010, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04291781
Lead sponsor
RemeGen Co., Ltd.
Responsible party
Sponsor
First posted
Mar 2, 2020
Start date
Apr 13, 2020
Primary completion
May 20, 2021
Completion
May 20, 2021
Last update
Sep 19, 2024

Study contacts

Hong Zhang, M.D.
principal investigator · Peking University First Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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