POVETACICEPT for Immunoglobulin A nephropathy (IgAN)

Inclusion criteria

• {"criterion_text":"- 1. Diagnosed IgAN, with biopsy confirmation"}
• {"criterion_text":"- 2. 24 hour proteinuria excretion greater than or equal to (≥)1.0 gram per day (g/day) or 24-hour uPCR ≥0.75 gram per gram (g/g)."}
• {"criterion_text":"- 3. Estimated glomerular filtration rate (eGFR) - ≥ 30 mL/min/1.73m2."}
• {"criterion_text":"- 4. Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) as per protocol specification."}

Exclusion criteria

• {"criterion_text":"- 1. Have received any immunosuppressive treatment or procedures (including corticosteroids, oral immunosuppressive agents, B cell or plasma cell targeted therapies, complement targeted therapies, herbal medicines per protocol, and tonsillectomy) within a wash-out period per protocol."}
• {"criterion_text":"- 2. Rapidly progressive glomerulonephritis with eGFR reduction >50% within 12 weeks of the start of screening."}
• {"criterion_text":"- 3. Other protocol defined Inclusion/Exclusion criteria may apply."}

Primary endpoints

• {"endpoint_text":"- 1. Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36 [Time Frame: From Baseline at Week 36].","definition_or_measurement_approach":"Change from baseline in 24-hour urine protein-to-creatinine ratio (uPCR) measured at Week 36 compared with baseline (24-hour urine collection)."}
• {"endpoint_text":"- 2. Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104 [Time Frame: From Baseline Through Week 104].","definition_or_measurement_approach":"Slope of estimated glomerular filtration rate (eGFR) over time from baseline through Week 104 (rate of change in eGFR)."}

Secondary endpoints

• {"endpoint_text":"- 3. Change From Baseline in eGFR at Week 104 [Time Frame: From Baseline at Week 104].","definition_or_measurement_approach":"Change from baseline in eGFR measured at Week 104 compared with baseline."}
• {"endpoint_text":"- 4. Time to Kidney Disease Progression Through Week 104 Kidney disease progression defined as greater than or equal to (≥) 30% decline in eGFR, end stage kidney disease, or non-accidental death. [Time Frame: From Baseline Through Week 104].","definition_or_measurement_approach":"Time from baseline to first occurrence of kidney disease progression, defined as ≥30% decline in eGFR, onset of end-stage kidney disease, or non-accidental death, assessed through Week 104."}
• {"endpoint_text":"- 1. Change from baseline in serum Gd-IgA1 at Week 36","definition_or_measurement_approach":"Change from baseline in serum galactose-deficient IgA1 (Gd-IgA1) measured at Week 36."}
• {"endpoint_text":"- 2. Proportion of subjects to achieve hematuria resolution at Week 36 (among subjects with hematuria at baseline)","definition_or_measurement_approach":"Proportion of baseline-hematuria subjects who achieve hematuria resolution by Week 36."}

Methods

• Brochure/Trifold (participant brochure) — printed recruitment materials provided to potential participants (country-specific versions available).
• Participant flyers — printed handouts for participants (country-specific).
• Participant posters — site posters for visibility at recruiting centres (country-specific).
• HCP-targeted materials: Dear Colleague letters, HCP PowerPoint, HCP flyers and posters to engage referring healthcare professionals.
• Digital adverts and website package for online recruitment (digital advert pack explicitly referenced for Germany).
• Pre-screening checklist and pre-screener packages to identify eligible participants.
• GP letters and site-specific contact information lists to support referrals.

Primary sponsor

Full Name

Alpine Immune Sciences Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

PPD Global Central Labs

Responsibilities

[{"code":"4"}], laboratory/central lab services

Name

PPD Development LP

Responsibilities

[{"code":"4"}], development/Central lab or operational support

Name

Medpace Finland Oy

Responsibilities

[{"code":"1"},{"code":"10"},{"code":"11"},{"code":"2"},{"code":"3"},{"code":"5"},{"code":"6"},{"code":"8"}], CRO operational and study management functions

Name

Suvoda LLC

Responsibilities

[{"code":"3"}], eClinical/electronic data capture support

Third parties

• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"[{\"code\":\"4\"}], contact Siteservices.eu@ppdi.com","organisation_type":"Pharmaceutical company"}
• {"country":"Finland","full_name":"Medpace Finland Oy","duties_or_roles":"[{\"code\":\"1\"},{\"code\":\"10\"},{\"code\":\"11\"},{\"code\":\"2\"},{\"code\":\"3\"},{\"code\":\"5\"},{\"code\":\"6\"},{\"code\":\"8\"}], contact RS-Advisor-Support@medpace.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"code\":\"4\"}], contact deborah.ferstl@ppd.com","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Inivata Limited","duties_or_roles":"[{\"code\":\"4\"}], contact inv-uklabteam@neogenomics.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Fisher Clinical Services Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Drug supply and Depot\"}], contact SharedDistributionMountProspect@thermofisher.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Veeva Systems Inc.","duties_or_roles":"[{\"code\":\"5\"},{\"code\":\"6\"}], contact CDMS_Support@veeva.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Suvoda LLC","duties_or_roles":"[{\"code\":\"3\"}], contact support@suvoda.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"[{\"code\":\"4\"}], contact ingo@bioagilytix.com","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"[{\"code\":\"5\"}], contact info@scoutclinical.com","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Long-term storage\"}], contact services@resonantclinical.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Nephropathology Associates PLC","duties_or_roles":"[{\"code\":\"4\"}], contact support@arkanalabs.com","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"[{\"code\":\"5\"}], contact support@greenphire.com","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"G1 Therapeutics Inc.","duties_or_roles":"[{\"code\":\"15\",\"value\":\"Tracking and documentation of samples\"}], contact support@trulab.com","organisation_type":"Pharmaceutical company"}