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Focal Segmental Glomerulosclerosis (FSGS)Phase 2PODONCT03448692

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

A Phase 2 study testing PF-06730512 in people with Focal Segmental Glomerulosclerosis (FSGS), run by Pfizer at 110 sites in 12 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PF-06730512
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
110 sitesin 12 countries
Study dates
15 Oct 2018to 14 Feb 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Urine protein:creatinine ratio (UPCR) greater than 1.5 g/g at screening.
  • 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.

Who cannot join

  • Diagnosis of collapsing FSGS.
  • Advanced chronic changes on renal biopsy as evidenced by greater than 50% tubulointerstitial fibrosis.
  • Organ transplant.
  • 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.
  • Body mass index (BMI) greater than 45 kg/m2.
  • 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.

Trial locations and contacts

110 sites in 12 countries.

110 sites in 12 countries

United States56 sites

  • The Kirklin Clinic of University Alabama Birmingham Hospital

    Birmingham, Alabama, 35233

  • Investigational Drug Service Pharmacy UAB Hosptial

    Birmingham, Alabama, 35249

  • Clinical Research Unit at UAB Hospital

    Birmingham, Alabama, 35294

  • UAB Nephrology Research Clinic at Paula Building

    Birmingham, Alabama, 35294

  • Boston Medical Center - Interventional Radiology

    Boston, Massachusetts, 02118

  • Boston Medical Center - Nephrology

    Boston, Massachusetts, 02118

  • Boston Medical Center

    Boston, Massachusetts, 02118

  • Boston University - GCRU

    Boston, Massachusetts, 02118

  • UNC Eastowne

    Chapel Hill, North Carolina, 27514

  • UNC Clinical and Translational Research Center

    Chapel Hill, North Carolina, 27599-7064

  • University of Cincinnati at DCI McMillan Research Unit

    Cincinnati, Ohio, 45206

  • Hoxworth Center Subspecialties Clinic

    Cincinnati, Ohio, 45219

  • UC Health Barrett Center

    Cincinnati, Ohio, 45219

  • UC Health Medical Arts Building

    Cincinnati, Ohio, 45219

  • University of Cincinnati Gardner Neuroscience Institute

    Cincinnati, Ohio, 45229

  • The Cleveland Clinic - Investigational Drug Pharmacy

    Cleveland, Ohio, 44195

  • The Cleveland Clinic

    Cleveland, Ohio, 44195

  • CarePoint East at The Ohio State University

    Columbus, Ohio, 43203

  • The Ohio State University Clinical Research Center

    Columbus, Ohio, 43210

  • The Ohio State University Investigational Drug Services

    Columbus, Ohio, 43210

  • The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit

    Columbus, Ohio, 43210

  • The Ohio State University

    Columbus, Ohio, 43210

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Kidney and Hypertension Care Center, PA

    Houston, Texas, 77004

  • Southside Pharmacy

    Houston, Texas, 77030

  • Prolato Clinical Research Center (PCRC)

    Houston, Texas, 77054

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Clinical Research Consultants, LLC

    Kansas City, Missouri, 64111

  • St. Luke's Hospital

    Kansas City, Missouri, 64111

  • Georgia Nephrology Research Institute

    Lawrenceville, Georgia, 30046

  • Georgia Nephrology

    Lawrenceville, Georgia, 30046

  • Johnson County Clin Trials

    Lenexa, Kansas, 66219

  • Academic Medical Research Institute

    Los Angeles, California, 90022

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • Cedars-Sinai Ambulatory Infusion Center

    Los Angeles, California, 90048

  • Cedars-Sinai Comprehensive Transplant Center

    Los Angeles, California, 90048

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095

  • UCLA Clinical and Translational Research Center

    Los Angeles, California, 90095

  • UCLA Department of Medicine

    Los Angeles, California, 90095

  • University of Miami Hospital and Clinics

    Miami, Florida, 33136

  • University of Miami Katz Family Division of Nephrology

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, 33136

  • Yale Center for Clinical Investigation Hospital Research Unit

    New Haven, Connecticut, 06510

  • Yale Nephrology Clinical Research Clinic

    New Haven, Connecticut, 06510

  • Yale University School of Medicine - Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Yale University

    New Haven, Connecticut, 06510

  • Yale New Haven Hospital

    New Haven, Connecticut, 06511

  • Yale Center for Clinical Investigation - Church Street Research Unit

    New Haven, Connecticut, 06519

  • New York University Grossman School of Medicine - CTSI

    New York, New York, 10016

  • Clinical and Translation Research Unit

    Palo Alto, California, 94304

  • Stanford University-Nephrology Division

    Palo Alto, California, 94304

  • University of California, San Francisco

    San Francisco, California, 94143

  • Stanford Health Care Investigational Pharmacy

    Stanford, California, 94305

  • Stanford University-Nephrology Division

    Stanford, California, 94305

  • Stanford University

    Stanford, California, 94305

  • Baylor Scott & White Clinic - Temple South Loop

    Temple, Texas, 76502

Other trials in United States

Canada12 sites

  • University of Alberta - Pharmacy Research Office

    Edmonton, Alberta, T6G 1Z1

  • University of Alberta - Clinical Investigation Unit

    Edmonton, Alberta, T6G 287

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

    Montreal, Quebec, H4A 3J1

  • CHU de Quebec-Universite Laval

    Québec, G1R 2J6

  • Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB

    Toronto, Ontario, M4G 3E8

  • University Health Network

    Toronto, Ontario, M5G 2C4

  • Pacific Nephrology Group

    Vancouver, British Columbia, V5Z 1M9

  • Vancouver General Hospital/Vancouver Coastal Health

    Vancouver, British Columbia, V5Z 1M9

  • St. Paul's Hospital/Providence Health Care

    Vancouver, British Columbia, V6Z 1Y6

  • St. Paul's Hospital/Providence Health Care

    Vancouver, British Columbia, V6Z 2K8

Other trials in Canada

Germany9 sites

  • Universitaetsklinikum Aachen

    Aachen, 52074

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10117

  • Uniklinik Koeln

    Cologne, 50937

  • Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie

    Dresden, Saxony, 01307

  • Universitaetsklinikum Erlangen

    Erlangen, 91054

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitaetsklinikum Mannheim

    Mannheim, 68167

  • Nephrologisches Zentrum Villingen-Schwenningen

    Villingen-Schwenningen, 78052

  • Sidonia Apotheke

    Villingen-Schwenningen, 78052

Other trials in Germany

United Kingdom6 sites

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB2 0QQ

  • University Hospitals Coventry & Warwickshire NHS Trust

    Coventry, CV2 2DX

  • Oxford University Hospitals NHS Foundation Trust

    Headington, Oxford, OX3 7LE

  • St. George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

  • Hammersmith Hospital

    London, W12 0HS

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

Other trials in United Kingdom

Japan5 sites

  • National Hospital Organization Chiba-East Hospital

    Chiba, 260-8712

  • Nagoya University Hospital

    Nagoya, Aichi-ken, 466-8560

  • Niigata University Medical & Dental Hospital

    Niigata, 951-8510

  • Tohoku University Hospital

    Sendai, Miyagi, 980-8574

  • Osaka University Hospital

    Suita, Osaka, 565-0871

Other trials in Japan

Poland4 sites

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej

    Lodz, 92-213

  • Apteka Szpitalna SPZOZ

    Lodz, 92-216

  • Centrum Zdrowia MDM

    Warsaw, 00-631

  • Miedzyleski Szpital Specjalistyczny w Warszawie

    Warsaw, 04-749

Other trials in Poland

Slovakia4 sites

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 01

  • Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica

    Banská Bystrica, 975 17

  • Univerzitna nemocnica Bratislava

    Bratislava, 831 01

  • Narodny ustav detskych chorob

    Bratislava, 833 40

Other trials in Slovakia

Spain4 sites

  • Hospital Universitario Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Público Da Mariña

    Burela de Cabo, LUGO, 27880

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

Other trials in Spain

France3 sites

  • Hopital Henri Mondor

    Créteil, 94010

  • CHU de Nice - Hopital Pasteur

    Nice, 06001

  • Hopital Necker - Enfants Malades

    Paris, 75015

Other trials in France

Mexico3 sites

  • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

    Mexico City, 14080

  • Hospital Universitario "Dr Jose Eleuterio Gonzalez"

    Monterrey, Nuevo León, 64460

  • SMIQ S de RL de CV

    Querétaro, 76070

Other trials in Mexico

Czechia2 sites

  • Fakultni nemocnice Hradec Kralove

    Hradec Králové, 500 05

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08

Other trials in Czechia

Italy2 sites

  • Asst Papa Giovanni Xxiii

    Bergamo, 24127

  • Ics Maugeri Spa-Sb Irccs

    Pavia PV, Pavia, 27100

Other trials in Italy

About this study

Official 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)

The purpose of this Phase 2 adaptive study is to evaluate the efficacy, safety, tolerability and pharmacokinetics of PF-06730512 following multiple intravenous infusions in adult subjects with FSGS.

Being tested
PF-06730512
Keywords
Proteinuria
Medical subject headings
Glomerulosclerosis, Focal Segmental, Proteinuria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PF-06730512Drug

    Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV. Subjects in cohort 3 will receive Dose 3 IV infusion.

Study groups in NCT03448692
Study groupRoleWhat they receive
PF-06730512 Cohort 1ExperimentalSubjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
Receives: Drug: PF-06730512
PF-06730512 Cohort 2ExperimentalSubjects in cohort 2 will receive dose 2 IV infusion.
Receives: Drug: PF-06730512
PF-06730512 Cohort 3 (optional)ExperimentalSubjects in cohort 3 will receive dose 3 IV infusion.
Receives: Drug: PF-06730512

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13

    UPCR is a ratio between two measured substances in urine: milligram of protein per millimole (mmol) of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.

    Measured: Baseline, Week 13

Secondary outcomes (11)

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An adverse event was considered treatment emergent relative to a given treatment if the event occurred for the first time during the investigational treatment period and was not seen prior to the start of treatment (during the lead-in period), or the event was seen prior to the start of treatment but increased in severity during treatment. Adverse events occurring during the lead-in period were considered non-treatment emergent. Events that occurred during the follow-Up period were counted as treatment emergent and attributed to the previous treatment taken.

    Measured: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)

  2. Number of Participants With Abnormalities in Laboratory Test Parameters

    Hemoglobin (Hg), hematocrit, erythrocytes: <0.8*lower limits of normal (LLN); platelets: <0.5*LLN>1.75*upper limits of normal(ULN); leukocytes (leu), glucose-fasting:<0.6*LLN>1.5*ULN; lymphocytes (lym), lym/leu, neutrophils(neu),neu/leu, protein, albumin, phosphate, free thyroxine, thyroid stimulating hormone: <0.8*LLN>1.2*ULN; basophils (bas), bas/leu, eosinophils (eos), eos/leu, monocytes(mon), mon/leu: >1.2*ULN; bilirubin (total, direct, indirect):>1.5*ULN; aspartate aminotransferase(AT), alanine AT, lactate dehydrogenase, alkaline phosphatase:>3.0*ULN; blood urea nitrogen, creatinine, cholesterol (total,LDL,HDL),triglycerides, Hg A1C: >1.3*ULN; sodium: <0.95*LLN>1.05*ULN; potassium, chloride, calcium, magnesium, bicarbonate: <0.9*LLLN>1.1*ULN; prolactin: >1.1*ULN; creatine kinase: >2.0*ULN; urobilinogen: >=1; Urine-specific gravity: <1.003>1.030, pH: <4.5 >8, glucose,protein,bilirubin,nitrite,leukocyte esterase, ketones: >=1.Categories with at-least 1 non-zero values are reported.

    Measured: From Day 1 of treatment up to Week 33

  3. Change From Baseline in Body Weight

    Change from baseline in body weight and at baseline values were reported for this outcome measure.

    Measured: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

  4. Change From Baseline in Blood Pressure

    Change from baseline in blood pressure and at baseline values were reported for this outcome measure.

    Measured: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

  5. Change From Baseline in Pulse Rate

    Change from baseline in pulse rate and at baseline values were reported for this outcome measure.

    Measured: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

  6. Change From Baseline in Body Temperature

    Change from baseline in body temperature and at baseline values were reported for this outcome measure.

    Measured: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33

  7. Number of Participants With Abnormalities in Electrocardiogram (ECG)

    ECG abnormalities criteria included: 1) QTc interval adjusted according to Bazett formula (QTcB) in millisecond (msec): greater than (>) 450, >480, >500, increase from baseline >30, increase from baseline >60; 2) QTc interval adjusted according to Fridericia formula (QTcF) (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60; 3) Heart rate (bpm): RR decrease >25% and to a VR (interval between QRS wave and T wave on ECG) >100; RR (interval between 2 successive R waves on ECG) increase >25% and to a VR <50; 4) Pulse rate (msec): increase >25% and to a value >200; 5) QT (msec): >450, >480, >500, increase from baseline >30, increase from baseline >60; 6) QRS (msec): increase >25% and to a value >110. Categories (timepoints) with at least 1 participant having ECG abnormality in any of the reporting arms, were reported for this outcome measure.

    Measured: Weeks 3, 7, 11, 13, 17, 21, 25, 33

  8. Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13

    UPCR is a ratio between two measured substances in urine: mmol of creatinine, reported in units mg/mmol. A decrease in UPCR may be associated with improved renal and cardiovascular function.

    Measured: Baseline, Weeks 2, 5, 9 and 13

  9. Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13

    The eGFR was calculated using 4 variable formula developed by the modification of diet in renal disease (MDRD) study group. The 4 variables needed to estimate glomerular filtration rate (GFR) using this formula were serum creatinine concentration, age, sex (for females, eGFR was multiplied by 0.742) and ethnic origin (for African-Caribbean people only, eGFR was multiplied by 1.212). Thus eGFR in milliliter per minute per 1.73 square meter (mL/min/1.73 m^2) = 175*(sCr/88.4)^-1.154*(Age)^-0.203*(0.742 if female)*(1.212 if African-Caribbean). Baseline eGFR was determined predose at Week 0 (Day 1). For Baseline eGFR, the "Low eGFR" group was defined as baseline eGFR < 45 mL/min/1.73m2, and the "High eGFR" group was defined as baseline eGFR > 45 mL/min/1.73 m2.

    Measured: Baseline, Weeks 3, 5, 9 and 13

  10. Serum PF-06730512 Concentration Versus Time Summary

    Measured: 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)

  11. Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)

    Number of participants with positive ADA and/or NAb were reported for this outcome measure.

    Measured: From Day 1 of treatment up to Week 33

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2018
  2. Study start15 Oct 2018
  3. Primary completion14 Feb 2023
  4. Study completion14 Feb 2023

Why it stopped: 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.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03448692
Sponsor's protocol ID
C0221002
Other IDs
2019-003607-35, ROBO2, PODO, 2019
Acronym
PODO
Status last verified
Apr 2024
First submitted
22 Feb 2018
Last updated
18 Apr 2024
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Beck LH Jr, Berasi SP, Copley JB, Gorman D, Levy DI, Lim CN, Henderson JM, Salant DJ, Lu W. PODO: Trial Design: Phase 2 Study of PF-06730512 in Focal Segmental Glomerulosclerosis. Kidney Int Rep. 2021 Apr 3;6(6):1629-1633. doi: 10.1016/j.ekir.2021.03.892. eCollection 2021 Jun.

    PubMed 34169203

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PF-06730512 in people with Focal Segmental Glomerulosclerosis (FSGS), run by Pfizer at 110 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 110 sites in United States, Canada, Germany, United Kingdom, Japan and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03448692, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2024.

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