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Trials |  |
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- | Enrollment change, Trial termination: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Apr 10, 2023
P2, N=47, Terminated, Sponsor: Pfizer
N=35 --> 47 | Active, not recruiting --> Terminated; The study was terminated due to lack of efficacy at both tested doses on 5th December 2022. The decision to terminate the study is not related to a safety concern.
- | Trial completion date, Trial primary completion date: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Dec 23, 2022
P2, N=35, Active, not recruiting, Sponsor: Pfizer
The decision to terminate the study is not related to a safety concern. Trial completion date: Aug 2025 --> Feb 2023 | Trial primary completion date: Aug 2025 --> Feb 2023
- PF-06730512 / Pfizer
Therapeutic Blockade of the SLIT/ROBO Signaling Pathway Alleviates Podocytopathy Defects in Integrin-Linked Kinase Podocyte-Specific Knockout Mice (Exhibit Hall, Orange County Convention Center, West Building) - Oct 13, 2022 - Abstract #KIDNEYWEEK2022KIDNEY_WEEK_1562;
P2
Our studies provide additional confidence in rationale for blocking the ROBO/SLIT signaling pathway for treating podocytopathies and proteinuric kidney diseases. A phase 2 (NCT03448692) clinical trial testing the efficacy of a ROBO2-Fc fusion protein (PF-06730512) in FSGS patients is ongoing.
- ||| Enrollment closed, Enrollment change: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Aug 18, 2022
P2, N=30, Active, not recruiting, Sponsor: Pfizer
A phase 2 (NCT03448692) clinical trial testing the efficacy of a ROBO2-Fc fusion protein (PF-06730512) in FSGS patients is ongoing. Recruiting --> Active, not recruiting | N=44 --> 30
- || PF-06730512 / Pfizer
Clinical, P1 data, PK/PD data, Journal: A Phase 1 first-in-human study of the safety, tolerability, and pharmacokinetics of the ROBO2 fusion protein PF-06730512 in healthy participants. (Pubmed Central) - Feb 12, 2022
P1
Further trials in patients with FSGS are warranted. Clinical trial registration: Clinicaltrials.gov: NCT03146065.
- ||| Enrollment change: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Feb 11, 2022
P2, N=44, Recruiting, Sponsor: Pfizer
Clinical trial registration: Clinicaltrials.gov: NCT03146065. N=66 --> 44
- ||| Enrollment change, Trial completion date, Trial primary completion date: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Jan 27, 2022
P2, N=66, Recruiting, Sponsor: Pfizer
N=66 --> 44 N=44 --> 66 | Trial completion date: Feb 2024 --> Aug 2025 | Trial primary completion date: Feb 2024 --> Aug 2025
- PF-06730512 / Pfizer
[VIRTUAL] PODO: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis (FSGS) - Results from First Interim Analysis () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_3949;
P2
Conclusion In this interim analysis (n=9), a significant mean reduction in UPCR was observed in FSGS subjects after 12 weeks of treatment with PF-06730512. PF-06730512 thus far is safe and well-tolerated.
- PF-06730512 / Pfizer
[VIRTUAL] PODO: A Phase 2 Multicenter, Open-Label, Adaptive, Sequential Cohort Trial of PF-06730512 in Adult Subjects With Focal Segmental Glomerulosclerosis (FSGS) () - Oct 17, 2021 - Abstract #KIDNEYWEEK2021KIDNEY_WEEK_2849;
P2
Secondary endpoints include safety and changes in eGFR. The PODO trial will provide information about the efficacy and safety of PF-06730512 inhibition of the ROBO2 pathway and its impact on podocyte injury in FSGS.
- || PF-06730512 / Pfizer
P2 data, Journal: PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis. (Pubmed Central) - Jun 29, 2021
P2
This ongoing trial will report the efficacy, safety, pharmacokinetics, and biomarker results of PF-06730512 for patients with FSGS. Findings from this proof-of-concept study may support further development and evaluation of PF-06730512 to treat FSGS and warrant assessment in phase 3 clinical trials.
- | Trial completion date, Trial primary completion date: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Mar 8, 2021
P2, N=44, Recruiting, Sponsor: Pfizer
Findings from this proof-of-concept study may support further development and evaluation of PF-06730512 to treat FSGS and warrant assessment in phase 3 clinical trials. Trial completion date: May 2023 --> Feb 2024 | Trial primary completion date: May 2023 --> Feb 2024
- | PF-06730512Â / Pfizer
Preclinical, Journal: Development of a Cell-Based Assay for the Detection of Neutralizing Antibodies to PF-06730512 Using Homogenous Time-Resolved Fluorescence. (Pubmed Central) - Jan 27, 2021
Herein, we describe the development of the assay with a focus on the challenges faced, including drug and blood collection tube interferences in NAb detection. The outcome of our efforts was a robust assay capable of detecting 1 μg/mL of a NAb positive control in the presence of clinically relevant drug concentrations up to 30 μg/mL.
- | PF-06730512Â / Pfizer
PF-06730512, a promising candidate for the treatment of podocyte injuries. Live at #KidneyWk (Twitter) - Oct 25, 2020
- PF-06730512Â / Pfizer
[VIRTUAL] A ROBO2 Fusion Protein (PF-06730512) Traps SLIT Ligands and Therapeutically Ameliorates Podocyte Injury (Simulive) - Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_3541;
P2
Inhibiting the ROBO2/SLIT2 pathway therapeutically reduces proteinuria and improves podocyte ultrastructure. A phase 2 clinical trial to evaluate the safety and efficacy of ROBO2-Fc (PF-06730512) in patients with FSGS is currently ongoing (NCT03448692).
- PF-06730512Â / Pfizer
[VIRTUAL] PODO: A Phase 2 Multicenter, Open-Label, Adaptive, Sequential Cohort Trial of PF-06730512 in Adult Subjects with Focal Segmental Glomerulosclerosis (FSGS) (On-Demand) - Oct 11, 2020 - Abstract #KIDNEYWEEK2020KIDNEY_WEEK_2647;
P2
The PODO trial will provide information about the efficacy and safety of PF-06730512 inhibition of the ROBO2 pathway and its impact on podocyte injury in FSGS. Funding: Pfizer Inc
- | Trial completion date, Trial primary completion date: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Feb 27, 2020
P2, N=44, Recruiting, Sponsor: Pfizer
Funding: Pfizer Inc Trial completion date: Mar 2021 --> Jan 2023 | Trial primary completion date: Mar 2021 --> Jan 2023
- | Trial completion date, Trial primary completion date: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Jan 31, 2019
P2, N=44, Recruiting, Sponsor: Pfizer
Trial completion date: Mar 2021 --> Jan 2023 | Trial primary completion date: Mar 2021 --> Jan 2023 Trial completion date: Jul 2021 --> Mar 2021 | Trial primary completion date: Jul 2021 --> Mar 2021
- || Enrollment open: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Jun 7, 2018
P2, N=44, Recruiting, Sponsor: Pfizer
Trial completion date: Jul 2021 --> Mar 2021 | Trial primary completion date: Jul 2021 --> Mar 2021 Not yet recruiting --> Recruiting
- | New P2 trial: PODO: A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (clinicaltrials.gov) - Feb 28, 2018
P2, N=44, Not yet recruiting, Sponsor: Pfizer
- ||| Enrollment open: Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512 (clinicaltrials.gov) - Jun 5, 2017
P1, N=78, Recruiting, Sponsor: Pfizer
Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
- ||| New P1 trial: Evaluation Of Safety, Tolerability And Pharmacokinetics Of Single And Multiple Doses Of PF-06730512 (clinicaltrials.gov) - May 9, 2017
P1, N=78, Not yet recruiting, Sponsor: Pfizer