A Study to Determine if BHV-1400 is Effective and Safe in Adults With IgA Nephropathy

Официальное название

A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of BHV-1400 in the Treatment of IgA Nephropathy

Обзор

The purpose of this study is to determine if BHV-1400 is effective and safe in the treatment of IgA Nephropathy. Participants will be randomized in a 2:1 ratio to receive either BHV-1400 or placebo.

Вмешательства

• Препарат BHV-1400
  500 mg delivered subcutaneously via autoinjector
• Препарат Placebo
  Matching placebo delivered subcutaneously via autoinjector

Первичные конечные точки

• Change from baseline in natural log-transformed Urine Protein to Creatinine Ratio (UPCR) at Week 52 [Срок оценки: Baseline to Week 52]

Вторичные конечные точки (12)

• Change from baseline in GdIgA1 at Week 52 [Срок оценки: Baseline to Week 52]
• Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) at Week 52 [Срок оценки: Baseline to Week 52]
• Time to Gd-IgA1 reduction greater than or equal to 50% during double-blind (DB) treatment phase [Срок оценки: Up to 52 weeks]
• Time to UPCR reduction greater than or equal to 30% during double-blind (DB) treatment phase [Срок оценки: Up to 52 weeks]
• Hematuria resolution at Week 52 (among participants with hematuria at baseline) [Срок оценки: Baseline to Week 52]
• Proportion of study participants reaching a Urinary Protein Excretion (UPE) below 0.5 g/d at Week 52 [Срок оценки: Baseline to Week 52]
• Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed during the DB Treatment Phase (up to 52 weeks) [Срок оценки: Up to 52 Weeks]
• Number of unique participants with Grade 3 to 4 lab abnormalities that are observed during the DB Treatment Phase (up to 52 weeks) [Срок оценки: Up to 52 Weeks]
• Change from baseline difference in the magnitude of the treatment effect (BHV-1400 versus placebo) in eGFR at Week 52. [Срок оценки: Baseline to Week 52]
• Number of participants experiencing any of the following during the DB phase: at least 30% reduction relative to baseline in eGFR for at least 30 days, eGFR <15 mL/min/1.73m2 for at least 30 days, chronic dialysis ≥30 days, kidney transplant, death [Срок оценки: Up to 52 Weeks]
• Number of unique participants with SAEs, AEs leading to discontinuation or deaths that are observed through the Open-label Treatment Phase [Срок оценки: Up to 104 Weeks]
• Number of unique participants with Grade 3 to 4 lab abnormalities that are observed through the Open-label Treatment Phase [Срок оценки: Up to 104 Weeks]

Критерии участия

Критерии включения

• Diagnosis of IgAN as confirmed by renal biopsy conducted within 10 years prior to Screening.

• If a participant has a history of diabetes, the biopsy must have been conducted within 2 years prior to Screening with no evidence of diabetic nephropathy.
• In all cases, if a historical biopsy report is not available, a biopsy may be performed prior to Screening.
• UPCR ≥ 0.75 g/g or UPE ≥ 1.0 g/d determined via 24 hour collection.
• eGFR ≥ 30 mL/min/1.73m2 (CKD-EPI equation).
• Participants must have been on supportive care including a stable dose regimen of ACEi or ARB (at the locally approved maximal daily dose or the maximally tolerated dose per Investigators' judgment) for at least 90 days prior to Screening. Subjects who are not able to tolerate ACEi or ARB therapy may be eligible for participation in the trial if their overall management including blood pressure control is as per local applicable guidelines. This must be discussed with the medical monitor and documented by the Investigator.
• Patients may be on a dual endothelin angiotensin receptor antagonist (DEARA) or endothelin receptor antagonist (ERA) but must be on a stable dose for at least 90 days prior to Screening and they must remain on a stable dose throughout the course of the study. Participants may be on a sodium-glucose cotransporter 2 (SGLT2) inhibitor, mineralocorticoid receptor antagonist (including Finerenone), but must be on a stable dose for 90 days prior to Screening and must remain on a stable dose throughout the course of the study.

Критерии исключения

• Any secondary IgAN as defined by the Investigator; secondary IgAN can be associated with cirrhosis, celiac disease, HIV infection, herpetiformis, seronegative arthritis, small-cell carcinoma, lymphoma, disseminated tuberculosis, bronchiolitis obliterans, inflammatory bowel disease, familial Mediterranean fever, etc. NOTE: IgA Vasculitis excluded if patient has had any IgA Vasculitis related extrarenal signs or symptoms, or requirement for steroid or other immunosuppressive therapy in the past year.
• Any cause of chronic kidney disease that is not diagnosed as IgAN or may be due to non-IgAN cause, such as diabetic nephropathy. If presence of other kidney disease or concurrent glomerulopathies felt to be non-dominant, consideration for inclusion must be discussed with and approved by the Sponsor Medical Monitor/Sponsor Designee.
• Presence of rapidly progressive glomerulonephritis as defined by 50% decline in eGFR within 3 months prior to Screening.
• Evidence of nephrotic syndrome, defined as 24-hour protein > 3.5g with concurrent hypoalbuminemia (Albumin < 3.0 g/dl), within 6 months of Screening
• End-stage renal disease requiring dialysis or transplantation

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07642050 · BHV1400-301

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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