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

• Register: ClinicalTrials.gov
• Last refreshed on: 29 April 2024
• Main ID: NCT03448692
• Date of registration: 22/02/2018
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) PODO
• Scientific title: A PHASE 2, 24-WEEK, ADAPTIVE, OPEN LABEL, SEQUENTIAL COHORT TRIAL TO EVALUATE THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06730512 FOLLOWING MULTIPLE DOSES IN ADULT SUBJECTS WITH FOCAL SEGMENTAL GLOMERULOSCLEROSIS (FSGS)
• Date of first enrolment: October 15, 2018
• Target sample size: 47
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/ct2/show/NCT03448692
• Study type: Interventional
• Study design: Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Canada, Czechia, France, Germany, Italy, Japan, Mexico, Poland, Slovakia, Spain, United Kingdom, United States

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Adults age 18 years and older who have a confirmed biopsy 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.

Exclusion Criteria:

1. Diagnosis of collapsing FSGS.

2. Advanced chronic changes on renal biopsy as evidenced by greater than 50%
tubulointerstitial fibrosis.

3. Organ transplant.

4. History of malignancy, with the exception of basal or squamous cell carcinoma that has
been treated and fully resolved for a minimum of 5 years.

5. Body mass index (BMI) greater than 45 kg/m2.

6. Subjects with a history of prior treatment with or use of interferon, lithium,
pamidronate, mTOR inhibitors (eg, sirolimus), testosterone/anabolic steroids,
anthracycline (eg, doxorubicin), heroin.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis (FSGS)

Intervention(s)

Drug: PF-06730512

Primary Outcome(s)

Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13 [Time Frame: Baseline, Week 13]

Secondary Outcome(s)

Change From Baseline in Body Temperature [Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33]

Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13 [Time Frame: Baseline, Weeks 3, 5, 9 and 13]

Change From Baseline in Body Weight [Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33]

Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) [Time Frame: From Day 1 of treatment up to Week 33]

Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13 [Time Frame: Baseline, Weeks 2, 5, 9 and 13]

Change From Baseline in Blood Pressure [Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33]

Change From Baseline in Pulse Rate [Time Frame: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33]

Serum PF-06730512 Concentration Versus Time Summary [Time Frame: For 12-Week treatment(WT):pre-dose on Day1,8,15,29,43,57,71,follow-up(Fup)visit on Day85,99,113,141,For 24-WT:pre-dose on Day1,8,15,29,43,57,71,85,99,113,127,141,155,Fup visit on Day169,183,197,225;1hour post-dose on Day1,71,155(only applicable for 24-WT)]

Number of Participants With Abnormalities in Electrocardiogram (ECG) [Time Frame: Weeks 3, 7, 11, 13, 17, 21, 25, 33]

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [Time Frame: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)]

Number of Participants With Abnormalities in Laboratory Test Parameters [Time Frame: From Day 1 of treatment up to Week 33]

Secondary ID(s)

PODO

C0221002

ROBO2

2019-003607-35

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 18/04/2024
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03448692