JPRN-jRCT2031220273
Recruiting
Phase 2
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects with Immunoglobulin A Nephropathy
Yano Hisako0 sites600 target enrollmentAugust 15, 2022
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Yano Hisako
- Enrollment
- 600
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\) Subjects who completed Trial 417\-201\-00007 or VIS649\-201 without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab.
- •2\) eGFR \>\= 20 mL/min/1\.73 m2, calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD\-EPI) formula.
Exclusion Criteria
- •1\) Subjects who have not completed participation in trials 417\-201\-00007 or VIS649\-201\.
- •2\) Subjects who, following enrollment in trials 417\-201\-00007 or VIS649\-201 developed a condition or characteristic that would have excluded them from participation in these trials.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Recruiting
Phase 2
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A NephropathyHealth Condition 1: N00-N99- Diseases of the genitourinary systemCTRI/2024/02/062883
Recruiting
Phase 1
Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)Treatment of IgANMedDRA version: 20.0Level: PTClassification code: 10021263Term: IgA nephropathy Class: 100000004857Therapeutic area: Diseases [C] - Immune System Diseases [C20]Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]Therapeutic area: Diseases [C] - Male Urogenital Diseases [C12]CTIS2023-507233-19-00Otsuka Pharmaceutical Development & Commercialization Inc.525
Active, not recruiting
Phase 1
This is a study to evaluate the long term safety of Tolvaptan in adults with chronic kidney disease.Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 20.0 Level: LLT Classification code 10036046 Term: Polycystic kidney, autosomal dominant System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2014-001516-19-BEOtsuka Pharmaceutical Development & Commercialization,2,500
Active, not recruiting
Phase 1
This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 18.0Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2014-001516-19-ESOtsuka Pharmaceutical Development & Commercialization,2,500
Active, not recruiting
Not Applicable
This is a study to evaluate the long term safety of Tolvaptan inadults with chronic kidney disease.Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 17.1Level: LLTClassification code 10036046Term: Polycystic kidney, autosomal dominantSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]EUCTR2014-001516-19-FROtsuka Pharmaceutical Development & Commercialization,2,500