IgA NephropathyPhase 2NCT04905212
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
A Phase 2 study testing Telitacicept 160mg and Telitacicept 240mg in people with IgA Nephropathy, run by RemeGen Co., Ltd. at 8 sites in United States.
Trial summary
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Telitacicept 160mg and Telitacicept 240mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 8 sitesUnited States
- Study dates
- 4 Nov 2021to 9 Nov 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- IgA nephropathy confirmed by pathological biopsy;
- Male or female aged ≥ 18 years old;
- Average 24-hour urine total protein ≥ 0.75 g/24 h
- Estimated GFR (using the CKD-EPI formula) > 30 mL/min per 1.73 m^2;
- Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.
Who cannot join
- Patients with clinically significant abnormal laboratory tests at screening;
- Evidence of rapid eGFR decrease > 15 ml/min during screening;
- Renal or other organ transplantation prior to, or expected during, the study;
- Patients with secondary IgA nephropathy;
- Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;
- Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
- Immunocompromised individuals.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Remegen Site #17
Augusta, Georgia, 30909
Remegen Site #16
Fort Lauderdale, Florida, 33071
Remegen Site #5
Los Angeles, California, 90022
Remegen Site #13
Los Angeles, California, 91324
Remegen Site #14
Los Angeles, California, 91324
Remegen Site #2
Philadelphia, Pennsylvania, 17033
Remegen Site #10
Sacramento, California, 95687
Remegen Site #8
San Francisco, California, 94080
About this study
Official title: A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
Read the detailed description
IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).
- Conditions
- IgA Nephropathy
- Being tested
- Telitacicept 160mg, Telitacicept 240mg, Placebo
- Keywords
- Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Primary IGA Nephropathy, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept 160mgDrug
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Telitacicept 240mgDrug
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
PlaceboDrug
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
| Study group | Role | What they receive |
|---|---|---|
| Telitacicept 160mg | Experimental | Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses Receives: Drug: Telitacicept 160mg |
| Telitacicept 240mg | Experimental | Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses Receives: Drug: Telitacicept 240mg |
| Placebo | Placebo comparator | Placebo subcutaneous injection once weekly, and a total of 24 doses Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in 24-hour urine protein at Week 24.
Change from baseline in urine protein over 24 hours to Week 24 will be measured
Measured: Week 24
Secondary outcomes (3)
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in eGFR by visit
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Change from baseline in Urine protein-to-creatinine ratio (UPCR) and Urine albumin-to-creatinine ratio (UACR) by visit.
Measured: Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Changes from baseline in Immunoglobulins (IgA, IgG, IgM), B lymphocytes (CD19+), complements (C3, C4)
Measured: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2021
- Study start4 Nov 2021
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Why it stopped: Decision that continuing with the study would not generate useful data
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for IgA NephropathyStudies of the same condition, open and under way.
- More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- RemeGen Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905212
- Sponsor's protocol ID
- RC18G004
- Status last verified
- Nov 2023
- First submitted
- 21 May 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
- ClinicalTrials.gov ID
- NCT04905212
- Acronym / sponsor ID
- RC18G004
- Conditions
- IgA Nephropathy
- Keywords
- Berger Disease, Berger's Disease, IGA Glomerulonephritis, IGA Nephropathy, Primary IGA Nephropathy, Immunoglobulin A Nephropathy Nephritis, IGA Type Nephropathy, IGA
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Decision that continuing with the study would not generate useful data
- Enrolment
- 15 participants (actual)
- Lead sponsor
- RemeGen Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 27 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled clinical study with an optional open label extension to evaluate the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
Detailed description
IgA nephropathy is a kidney disease in which IgA, a protein meant to defend the body against foreign invaders, accumulates in the kidneys and damages them. This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.
The study is composed of 4 parts: a screening period, a double-blind treatment period, an optional open label extension, and a follow-up period. Subjects with confirmed IgA nephropathy will be enrolled and randomized 1:1:1 to Telitacicept 160 mg, Telitacicept 240 mg, or placebo (10 per arm).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Telitacicept 160mg | Experimental | Drug: Telitacicept 160mgTelitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses |
| Telitacicept 240mg | Experimental | Drug: Telitacicept 240mgTelitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo subcutaneous injection once weekly, and a total of 24 doses |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- IgA nephropathy confirmed by pathological biopsy;
- Male or female aged ≥ 18 years old;
- Average 24-hour urine total protein ≥ 0.75 g/24 h
- Estimated GFR (using the CKD-EPI formula) > 30 mL/min per 1.73 m^2;
- Stabilized AEI/ARB medications, diuretics, or other antihypertensive therapy.
Key exclusion criteria (7 listed)
- Patients with clinically significant abnormal laboratory tests at screening;
- Evidence of rapid eGFR decrease > 15 ml/min during screening;
- Renal or other organ transplantation prior to, or expected during, the study;
- Patients with secondary IgA nephropathy;
- Patients with nephrotic syndrome, crescentic nephritis minimal change nephropathy with IgA deposition, or other pathological or clinical types of renal diseases that may confound the study data interpretation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telitacicept 160mgSubcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm. | Drug | Telitacicept 160mg |
| Telitacicept 240mgSubcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm. | Drug | Telitacicept 240mg |
| PlaceboSubcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm. | Drug | Placebo |
Primary outcome
Change from baseline in 24-hour urine protein at Week 24.
Time frame: Week 24
Change from baseline in urine protein over 24 hours to Week 24 will be measured
3 secondary outcomes
Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 36 and 48
Change from baseline in urine protein-to-creatinine ratio (UPCR) and urine albumin-to-creatinine ratio (UACR) at Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48;
Time frame: Weeks 4, 8, 12, 16, 20, 24, 32, 36, and 48
Change from baseline in immunological parameters (IgA, IgG, IgM, C3, C4, and B lymphocytes) at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Time frame: Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Results and safety
The study was stopped early (reason given: Decision that continuing with the study would not generate useful data). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Derived from this study: PubMed 38299639Tunnicliffe 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telitacicept 160mg and Telitacicept 240mg in people with IgA Nephropathy, run by RemeGen Co., Ltd. at 8 sites in United States.
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 5 inclusion and 7 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: stopped early, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. 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 was stopped early (reason given: Decision that continuing with the study would not generate useful data). Results are not available in the source record.
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 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 NCT04905212, which also lists 1 linked publication.
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 6 Dec 2023; AzTrials last refreshed its copy on 8 Nov 2026.