Study Stopped
Decision that continuing with the study would not generate useful data
A Study of Telitacicept for Injection (RC18) in Subjects With IgA Nephropathy
A Phase 2, Randomized, Double-Blind, Multicenter Study of Telitacicept for Injection (RC18) With an Optional Open Label Extension in Subjects With IgA Nephropathy
1 other identifier
interventional
15
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2021
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 21, 2021
CompletedFirst Posted
Study publicly available on registry
May 27, 2021
CompletedStudy Start
First participant enrolled
November 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 9, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2023
CompletedDecember 6, 2023
November 1, 2023
2 years
May 21, 2021
November 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
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
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;
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.
Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 48, and EOT visit.
Other Outcomes (4)
The incidence and severity of adverse events
27 weeks
Immunogenicity endpoints
Week 0, 4, 8, 12, 16, 20, 24 and 27
Biomaker endpoints serum concentration
Week 0, 4, 8, 12, 16, 20, and 24
- +1 more other outcomes
Study Arms (3)
Telitacicept 160mg
EXPERIMENTALTelitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses
Telitacicept 240mg
EXPERIMENTALTelitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses
Placebo
PLACEBO COMPARATORPlacebo subcutaneous injection once weekly, and a total of 24 doses
Interventions
Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Remegen Site #5
Los Angeles, California, 90022, United States
Remegen Site #13
Los Angeles, California, 91324, United States
Remegen Site #14
Los Angeles, California, 91324, United States
Remegen Site #10
Sacramento, California, 95687, United States
Remegen Site #8
San Francisco, California, 94080, United States
Remegen Site #16
Fort Lauderdale, Florida, 33071, United States
Remegen Site #17
Augusta, Georgia, 30909, United States
Remegen Site #2
Philadelphia, Pennsylvania, 17033, United States
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: 38299639DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
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
May 21, 2021
First Posted
May 27, 2021
Study Start
November 4, 2021
Primary Completion
November 9, 2023
Study Completion
November 9, 2023
Last Updated
December 6, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share