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.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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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.

City, postcode or hospital

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

Other trials in United States

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

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 groups in NCT04905212
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.

4 Nov 20219 Nov 2023

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

All IgA Nephropathy trials

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.

Detailed description

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

Related trials for IgA Nephropathy

RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 3
A Study of Mezagitamab in Adults With Kidney Condition Called IgA Nephropathy
Kidney Disease
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 2
Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of KP104 to Treat Glomerulonephritis
Glomerulonephritis
RecruitingPhase 3
A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
IgA Nephropathy (IgAN)

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.