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Primary IgA NephropathyPhase 2NCT04291781

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

A Phase 2 study testing RC18 160mg and RC18 240mg in people with Primary IgA Nephropathy, run by RemeGen Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Primary IgA Nephropathy
What is being tested?
RC18 160mg and RC18 240mg
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
44 participants
Where
1 siteChina
Study dates
13 Apr 2020to 20 May 2021
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.;
Show all 16Show fewer
  • 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;
  • Not suitable for the study judged by investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University First Hospital.

    Beijing, Beijing Municipality, 100010

Other trials in China

About this study

Official title: Phase II Clinical Trial of RC18(Recombinant Human B Lymphocyte Stimulator Receptor - Antibody Fusion Protein for Injection) in the Treatment of Primary IgA Nephropathy

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.

Being tested
RC18 160mg, RC18 240mg, placebo
Medical subject headings
Glomerulonephritis, IGA

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RC18 160mgBiological

    Also called Tai Ai, Recombinant Human B-Lymphocyte Stimulator Receptor- Antibody Fusion Protein

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

  • RC18 240mgBiological

    Also called Tai Ai, Recombinant Human B-Lymphocyte Stimulator Receptor- Antibody Fusion Protein

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

  • placeboBiological

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

Study groups in NCT04291781
Study groupRoleWhat they receive
RC18 160mgExperimentalRC18 160mg subcutaneous injection (S.C.) once weekly ,and a total of 24 doses
Receives: Biological: RC18 160mg
RC18 240mgExperimentalRC18 240mg S.C. once weekly ,and a total of 24 doses
Receives: Biological: RC18 240mg
PlaceboPlacebo comparatorPlacebo S.C. once weekly ,and a total of 24 doses
Receives: Biological: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    based on the 24 -hour urine collection

    Measured: week 24

Secondary outcomes (10)

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

    eGFR is calculated using the CKD-EPI method.

    Measured: 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)

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

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

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

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

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

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

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

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

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

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

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

  8. Change from baseline in complement 3（C3）

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

  9. Change from baseline in complement 4 (C4)

    Measured: 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2020
  2. Study start13 Apr 2020
  3. Primary completion20 May 2021
  4. Study completion20 May 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
44 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04291781
Sponsor's protocol ID
18C014
Status last verified
Sep 2024
First submitted
27 Feb 2020
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Pei J, Xu X, Huang R, Sun X, Zhang J, Chen X, Yao L, Zhang H, Shao L, Li Y. Efficacy and safety of low- to medium-dose telitacicept in adults with high-risk progressive IgA nephropathy: a retrospective real-world study. BMC Nephrol. 2025 Dec 17;27(1):92. doi: 10.1186/s12882-025-04708-w.

    PubMed 41408192

  • 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.

    PubMed 38299639

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RC18 160mg and RC18 240mg in people with Primary IgA Nephropathy, run by RemeGen Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in 24-hour urine protein excretion at Week 24; (time frame: week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04291781, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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