Active — Not RecruitingPhase 3

A Study of Telitacicept for IgA Nephropathy (TELIGAN)

China318 participantsStarted 2023-04-28

Plain-language summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Voluntary informed consent provided;
✓. Male or female aged ≥ 18 years old;
✓. IgA nephropathy confirmed by pathological biopsy;
✓. During the screening period, UPCR ≥ 0.8 g/g or 24-hour urine protein ≥ 1.0 g/day based on 24-hour urine collection at Visit 1 and/or Visit 2 and at Visit 3;
✓. eGFR ≥ 30 mL/min per 1.73 m\^2 (using the CKD-EPI);
✓. Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.

Exclusion criteria

✕. Subjects with abnormal laboratory tests, including but not limited to the following:
✕. White blood cell count \< 1.5×109/L
✕. Neutrophils \< 1.0×109/L
✕. Hemoglobin \< 85.0 g/L
✕. Platelet count \< 80.0×109/L
✕. Total bilirubin \>2×ULN
✕. ALT\>3×ULN
✕. AST\>3×ULN

What they're measuring

Change from baseline in urine protein creatinine ratio (UPCR)

Timeframe: 39 weeks

Annualized estimated glomerular filtration rate (eGFR) slope

Timeframe: 104 weeks

Trial details

NCT IDNCT05799287

SponsorRemeGen Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-06

View on ClinicalTrials.gov More Primary IgA Nephropathy trials