A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)

JRCT ID: jRCT2021200032

Registered date:16/12/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Focal Segmental Glomerulosclerosis (FSGS)
• Date of first enrollment: 17/05/2021
• Target sample size: 44
• Countries of recruitment: Canada,Japan,Spain,Japan,United States,Japan
• Study type: Interventional

Intervention(s)

Drug: PF-06730512
Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.

Outcome(s)

Primary Outcome

Primary Outcome Measures :
1.Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR). [ Time Frame: Baseline to 13 weeks ]

Secondary Outcome

Secondary Outcome Measures :
1.Percentage change from baseline in UPCR [ Time Frame: Baseline to Weeks 3, 5 and 9 ]
2.Number of partial remission events of proteinuria [ Time Frame: Week 13 ]
3.Number of complete remission events of proteinuria [ Time Frame: Week 13 ]
4.Percentage change from baseline in estimated glomerular filtration rate (eGFR) [ Time Frame: Baseline to Weeks 3, 5, 9 and 13 ]
5.Number of Adverse Events by Severity [ Time Frame: Baseline to Day 141 ]
6.Number of subjects with laboratory safety tests (Hematology, Clinical Chemistry, Urinalysis) abnormality [ Time Frame: Baseline to 13 weeks ]
7.Number of subjects with change in body weight [ Time Frame: Baseline to Day 141 ]
8.Number of subjects with increased blood pressure [ Time Frame: Baseline to Day 141 ]
9.Number of subjects with increased body temperature [ Time Frame: Baseline to Day 141 ]
10.Number of subjects with significant changes in pulse rate [ Time Frame: Baseline to Day 141 ]
11.Number of subjects with ECG abnormalities [ Time Frame: Baseline to Day 141 ]
12.Serum concentration of PF-06730512 [ Time Frame: Day 1 to Day 141 ]
13.Number of subjects with development of anti drug antibody (ADA) and neutralizing antibody (NAb) [ Time Frame: Day 1 to Day 141 ]

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

Inclusion Criteria:
1.Adults age 18 years and older who have a confirmed diagnosis of FSGS.
2.Estimated glomerular filtration rate (eGFR) greater than or equal to 45 ml/min/1.73 m2. If eGFR is 30 - 45 ml/min/1.73 m2, a recent biopsy (within 12 months prior to Screening) must demonstrate < 50% tubulointerstitial fibrosis.
3.Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
4.Treated with at least one but not more than 3 classes of immunosuppressants either alone or in combination, or has a contraindication to use of an immunosuppressant or is intolerant to an immunosuppressant per investigator judgment

Exclude criteria

Exclusion Criteria:
1.Diagnosis of collapsing FSGS.
2.Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
3.Body mass index (BMI) greater than 45 kg/m2.

Related Information

• Primary Sponsor: Kawai Norisuke
• Secondary ID(s): NCT03448692