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Monoclonal Antibodies

PF-06730512 for Focal Segmental Glomerulosclerosis (PODO Trial)

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults age 18 years and older who have a confirmed biopsy diagnosis of FSGS.
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to weeks 3, 5, 9, 13 and beyond as applicable
Awards & highlights

PODO Trial Summary

This trial is testing a new drug to see if it's effective and safe for people with FSGS.

Eligible Conditions
  • Focal Segmental Glomerulosclerosis

PODO Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

PODO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to weeks 3, 5, 9, 13 and beyond as applicable
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to weeks 3, 5, 9, 13 and beyond as applicable for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage change from baseline to Week 13 in Urinary Protein to Creatinine Ratio (UPCR).
Secondary outcome measures
Number of Adverse Events by Severity
Number of subjects with ECG abnormalities
Number of subjects with change in body weight
+8 more

PODO Trial Design

3Treatment groups
Experimental Treatment
Group I: PF-06730512 Cohort 3 (optional)Experimental Treatment1 Intervention
Subjects in cohort 3 will receive dose 3 IV infusion.
Group II: PF-06730512 Cohort 2Experimental Treatment1 Intervention
Subjects in cohort 2 will receive dose 2 IV infusion.
Group III: PF-06730512 Cohort 1Experimental Treatment1 Intervention
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF-06730512
2017
Completed Phase 1
~80

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,556 Previous Clinical Trials
10,907,636 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,467 Previous Clinical Trials
8,089,073 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this investigation still open?

"According to the clinicaltrials.gov records, this study is no longer actively seeking participants as of November 7th 2022. Although it cannot accept applicants at present, there are 15 other trials which currently require patient enrolment."

Answered by AI

Does PF-06730512 present any health hazards to trial participants?

"The safety of PF-06730512 has been judged to be a 2 on the 1-3 scale, since this is only in its second trial phase; there is some evidence indicating an acceptable level of security but none that confirms efficacy."

Answered by AI

Which settings are currently providing access to this trial?

"Patients can be accepted into this research trial at Stanford University-Nephrology Division, CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont, and UNC Clinical and Translational Research Center; additionally there are 63 other sites that have been approved."

Answered by AI
~7 spots leftby Mar 2025