NCT04905212TerminatedPhase 2
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
Source: ClinicalTrials.gov · Last updated 6 Dec 2023
Reason given: Decision that continuing with the study would not generate useful data
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 15 (actual)
- First submitted
- 21 May 2021
- Start date
- 4 Nov 2021
- Primary completion date
- 9 Nov 2023
- Lead sponsor
- RemeGen Co., Ltd.
- Diseases
- IgA nephropathy
- NCT number
- NCT04905212
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Renal or other organ transplantation prior to, or expected during, the study;
- Patients with history of any severe unstable cardiovascular and cerebrovascular events within 12 weeks prior to screening;
Other illness
- 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;
Lab values
- Patients with clinically significant abnormal laboratory tests at screening;
- Evidence of rapid eGFR decrease > 15 ml/min during screening;
Other
- Patients with secondary IgA nephropathy;
- Immunocompromised individuals.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - | Augusta | United States | Unknown status |
| - | Fort Lauderdale | United States | Unknown status |
| - | Los Angeles | United States | Unknown status |
| - | Los Angeles | United States | Unknown status |
| - | Los Angeles | United States | Unknown status |
| - | Philadelphia | United States | Unknown status |
| - | Sacramento | United States | Unknown status |
| - | San Francisco | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.