Effectiveness and Safety of Sparsentan as treatment for Immunoglobulin A Nephropathy (IgAN)

Phase 1

• Conditions: Immunoglobulin A Nephropathy (IgAN); MedDRA version: 20.0Level: PTClassification code 10021263Term: IgA nephropathySystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Symptoms and general pathology [C23]

• Registration Number: EUCTR2017-004605-41-IT
• Lead Sponsor: RETROPHIN, INC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-01-28
• Last Update Posted: 5 April 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 280

Inclusion Criteria

1. Male or female, aged =18 years.
2. Biopsy-proven primary IgAN.
3. Urine total protein value =1.0 g/day at screening.
4. eGFR =30 mL/min/1.73 m2 at screening.
5. The patient has been on a stable dose of ACEI and/or ARB therapy for
at least 12 weeks prior to screening.
6. At screening, systolic blood pressure =150 mmHg and diastolic blood
pressure =100 mmHg.
7. The patient must agree to the use of two forms of contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. IgAN secondary to another condition.
2. Cellular glomerular crescents present in >25% of glomeruli on renal
biopsy within 6 months prior to screening.
3. History of type 1 diabetes mellitus, uncontrolled type 2 diabetes mellitus (hemoglobin A1c [HbA1c] >8%), or nonfasting blood glucose
>180 mg/dL at screening.
4. Any organ transplantation, with the exception of corneal transplants.
5. Treatment with any of the prohibited concomitant medications.
6. Treatment with any systemic immunosuppressive medications
(including corticosteroids) for >2 weeks within 3 months prior to
screening.
7. Documented history of heart failure and/or previous hospitalization
for heart failure or unexplained dyspnea, orthopnea, paroxysmal
nocturnal dyspnea, ascites, and/or peripheral edema.
8. Clinically significant cerebrovascular disease and/or coronary artery
disease.
9. Jaundice, hepatitis, or known hepatobiliary disease (including
asymptomatic cholelithiasis), or transaminase levels >2 times the upper
limit of the normal range at screening.
10. History of malignancy other than adequately treated basal cell or
squamous cell skin cancer or cervical carcinoma within the past 2 years.
11. A screening hematocrit value <27% or hemoglobin value <9 g/dL.
12. A screening potassium value of >5.5 mEq/L.
13. Female patient is pregnant, breastfeeding or planning to conceive
during the study.
14. Male patient plans to father a child during the course of the study.
15. Participation in a study of another investigational product within 28
days prior to screening.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified