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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-003607-35 | EudraCT Number | ||
| ROBO2 | Other Identifier | Alias Study Number | |
| PODO | Other Identifier | Alias Study Number |
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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.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PF-06730512 Cohort 1 | Experimental | Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion. |
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| PF-06730512 Cohort 2 | Experimental | Subjects in cohort 2 will receive dose 2 IV infusion. |
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| PF-06730512 Cohort 3 (optional) | Experimental | Subjects in cohort 3 will receive dose 3 IV infusion. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PF-06730512 | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, Week 13 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Kirklin Clinic of University Alabama Birmingham Hospital | Birmingham | Alabama | 35233 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34169203 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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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.
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A total of 47 participants were enrolled into the study. All participants received treatment.
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| ID | Title | Description |
|---|---|---|
| FG000 | PF-06730512 1000 mg IV | Participants received PF-06730512 1000 milligram (mg) intravenously (IV) every 2 weeks (Q2W). |
| FG001 | PF-06730512 300 mg IV | Participants received PF-06730512 300 mg IV Q2W. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Disposition Phase:Screening:up to 43Days |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 18, 2021 | Feb 1, 2024 |
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Open label
| 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 | 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. | From Day 1 of treatment up to Week 33 |
| Change From Baseline in Body Weight | Change from baseline in body weight and at baseline values were reported for this outcome measure. | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
| Change From Baseline in Blood Pressure | Change from baseline in blood pressure and at baseline values were reported for this outcome measure. | 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 | Change from baseline in pulse rate and at baseline values were reported for this outcome measure. | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
| Change From Baseline in Body Temperature | Change from baseline in body temperature and at baseline values were reported for this outcome measure. | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
| 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. | Weeks 3, 7, 11, 13, 17, 21, 25, 33 |
| 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. | Baseline, Weeks 2, 5, 9 and 13 |
| 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. | Baseline, Weeks 3, 5, 9 and 13 |
| Serum PF-06730512 Concentration Versus Time Summary | 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 Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb) | Number of participants with positive ADA and/or NAb were reported for this outcome measure. | From Day 1 of treatment up to Week 33 |
| Investigational Drug Service Pharmacy UAB Hosptial |
| Birmingham |
| Alabama |
| 35249 |
| United States |
| Clinical Research Unit at UAB Hospital | Birmingham | Alabama | 35294 | United States |
| UAB Nephrology Research Clinic at Paula Building | Birmingham | Alabama | 35294 | United States |
| Academic Medical Research Institute | Los Angeles | California | 90022 | United States |
| Cedars Sinai Medical Center | Los Angeles | California | 90048 | United States |
| Cedars-Sinai Ambulatory Infusion Center | Los Angeles | California | 90048 | United States |
| Cedars-Sinai Comprehensive Transplant Center | Los Angeles | California | 90048 | United States |
| Ronald Reagan UCLA Medical Center | Los Angeles | California | 90095 | United States |
| UCLA Clinical and Translational Research Center | Los Angeles | California | 90095 | United States |
| UCLA Department of Medicine | Los Angeles | California | 90095 | United States |
| Clinical and Translation Research Unit | Palo Alto | California | 94304 | United States |
| Stanford University-Nephrology Division | Palo Alto | California | 94304 | United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Stanford Health Care Investigational Pharmacy | Stanford | California | 94305 | United States |
| Stanford University-Nephrology Division | Stanford | California | 94305 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| Yale Center for Clinical Investigation Hospital Research Unit | New Haven | Connecticut | 06510 | United States |
| Yale Nephrology Clinical Research Clinic | New Haven | Connecticut | 06510 | United States |
| Yale University School of Medicine - Yale-New Haven Hospital | New Haven | Connecticut | 06510 | United States |
| Yale University | New Haven | Connecticut | 06510 | United States |
| Yale New Haven Hospital | New Haven | Connecticut | 06511 | United States |
| Yale Center for Clinical Investigation - Church Street Research Unit | New Haven | Connecticut | 06519 | United States |
| University of Miami Hospital and Clinics | Miami | Florida | 33136 | United States |
| University of Miami Katz Family Division of Nephrology | Miami | Florida | 33136 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| Georgia Nephrology Research Institute | Lawrenceville | Georgia | 30046 | United States |
| Georgia Nephrology | Lawrenceville | Georgia | 30046 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Johnson County Clin Trials | Lenexa | Kansas | 66219 | United States |
| Boston Medical Center - Interventional Radiology | Boston | Massachusetts | 02118 | United States |
| Boston Medical Center - Nephrology | Boston | Massachusetts | 02118 | United States |
| Boston Medical Center | Boston | Massachusetts | 02118 | United States |
| Boston University - GCRU | Boston | Massachusetts | 02118 | United States |
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
| Clinical Research Consultants, LLC | Kansas City | Missouri | 64111 | United States |
| St. Luke's Hospital | Kansas City | Missouri | 64111 | United States |
| New York University Grossman School of Medicine - CTSI | New York | New York | 10016 | United States |
| UNC Eastowne | Chapel Hill | North Carolina | 27514 | United States |
| UNC Clinical and Translational Research Center | Chapel Hill | North Carolina | 27599-7064 | United States |
| University of Cincinnati at DCI McMillan Research Unit | Cincinnati | Ohio | 45206 | United States |
| Hoxworth Center Subspecialties Clinic | Cincinnati | Ohio | 45219 | United States |
| UC Health Barrett Center | Cincinnati | Ohio | 45219 | United States |
| UC Health Medical Arts Building | Cincinnati | Ohio | 45219 | United States |
| University of Cincinnati Gardner Neuroscience Institute | Cincinnati | Ohio | 45229 | United States |
| The Cleveland Clinic - Investigational Drug Pharmacy | Cleveland | Ohio | 44195 | United States |
| The Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| CarePoint East at The Ohio State University | Columbus | Ohio | 43203 | United States |
| The Ohio State University Clinical Research Center | Columbus | Ohio | 43210 | United States |
| The Ohio State University Investigational Drug Services | Columbus | Ohio | 43210 | United States |
| The Ohio State University Wexner Medical Center- Nephrology Clinical Trials Unit | Columbus | Ohio | 43210 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Kidney and Hypertension Care Center, PA | Houston | Texas | 77004 | United States |
| Southside Pharmacy | Houston | Texas | 77030 | United States |
| Prolato Clinical Research Center (PCRC) | Houston | Texas | 77054 | United States |
| Baylor Scott & White Clinic - Temple South Loop | Temple | Texas | 76502 | United States |
| University of Alberta - Pharmacy Research Office | Edmonton | Alberta | T6G 1Z1 | Canada |
| University of Alberta - Clinical Investigation Unit | Edmonton | Alberta | T6G 287 | Canada |
| University of Alberta Hospital | Edmonton | Alberta | T6G 2B7 | Canada |
| Pacific Nephrology Group | Vancouver | British Columbia | V5Z 1M9 | Canada |
| Vancouver General Hospital/Vancouver Coastal Health | Vancouver | British Columbia | V5Z 1M9 | Canada |
| St. Paul's Hospital/Providence Health Care | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| St. Paul's Hospital/Providence Health Care | Vancouver | British Columbia | V6Z 2K8 | Canada |
| Sunnybrook Health Sciences Centre - Kidney Care Centre at the CNIB | Toronto | Ontario | M4G 3E8 | Canada |
| University Health Network | Toronto | Ontario | M5G 2C4 | Canada |
| CIUSSS de l'Est-de-l'Ile-de-Montreal - installation Hopital Maisonneuve-Rosemont | Montreal | Quebec | H1T 2M4 | Canada |
| Centre for Innovative Medicine, Research Institute of the McGill University Health Centre | Montreal | Quebec | H4A 3J1 | Canada |
| CHU de Quebec-Universite Laval | Québec | G1R 2J6 | Canada |
| Fakultni nemocnice Hradec Kralove | Hradec Králové | 500 05 | Czechia |
| Vseobecna fakultni nemocnice v Praze | Prague | 128 08 | Czechia |
| Hopital Henri Mondor | Créteil | 94010 | France |
| CHU de Nice - Hopital Pasteur | Nice | 06001 | France |
| Hopital Necker - Enfants Malades | Paris | 75015 | France |
| Universitätsklinikum Dresden, Medizinische Klinik III, Nephrologie | Dresden | Saxony | 01307 | Germany |
| Universitaetsklinikum Aachen | Aachen | 52074 | Germany |
| Charite - Universitaetsmedizin Berlin | Berlin | 10117 | Germany |
| Uniklinik Koeln | Cologne | 50937 | Germany |
| Universitaetsklinikum Erlangen | Erlangen | 91054 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Universitaetsklinikum Mannheim | Mannheim | 68167 | Germany |
| Nephrologisches Zentrum Villingen-Schwenningen | Villingen-Schwenningen | 78052 | Germany |
| Sidonia Apotheke | Villingen-Schwenningen | 78052 | Germany |
| Ics Maugeri Spa-Sb Irccs | Pavia PV | Pavia | 27100 | Italy |
| Asst Papa Giovanni Xxiii | Bergamo | 24127 | Italy |
| Nagoya University Hospital | Nagoya | Aichi-ken | 466-8560 | Japan |
| Tohoku University Hospital | Sendai | Miyagi | 980-8574 | Japan |
| Osaka University Hospital | Suita | Osaka | 565-0871 | Japan |
| National Hospital Organization Chiba-East Hospital | Chiba | 260-8712 | Japan |
| Niigata University Medical & Dental Hospital | Niigata | 951-8510 | Japan |
| Hospital Universitario "Dr Jose Eleuterio Gonzalez" | Monterrey | Nuevo León | 64460 | Mexico |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | Mexico City | 14080 | Mexico |
| SMIQ S de RL de CV | Querétaro | 76070 | Mexico |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej | Lodz | 92-213 | Poland |
| Apteka Szpitalna SPZOZ | Lodz | 92-216 | Poland |
| Centrum Zdrowia MDM | Warsaw | 00-631 | Poland |
| Miedzyleski Szpital Specjalistyczny w Warszawie | Warsaw | 04-749 | Poland |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica | Banská Bystrica | 975 01 | Slovakia |
| Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica | Banská Bystrica | 975 17 | Slovakia |
| Univerzitna nemocnica Bratislava | Bratislava | 831 01 | Slovakia |
| Narodny ustav detskych chorob | Bratislava | 833 40 | Slovakia |
| Hospital Público Da Mariña | Burela de Cabo | LUGO | 27880 | Spain |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clinic Barcelona | Barcelona | 08036 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Oxford University Hospitals NHS Foundation Trust | Headington | Oxford | OX3 7LE | United Kingdom |
| Cambridge University Hospitals NHS Foundation Trust | Cambridge | CB2 0QQ | United Kingdom |
| University Hospitals Coventry & Warwickshire NHS Trust | Coventry | CV2 2DX | United Kingdom |
| St. George's University Hospitals NHS Foundation Trust | London | SW17 0QT | United Kingdom |
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
| Nottingham University Hospitals NHS Trust | Nottingham | NG5 1PB | United Kingdom |
| COMPLETED |
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| NOT COMPLETED |
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| Lead in Period:8 Weeks (W) |
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| Investigational Treatment Period:Upto24W |
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| Follow up Period:9 Weeks |
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Safety Analysis Set (SAS) was defined as all enrolled participants who had received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | PF-06730512 1000 mg IV | Participants received PF-06730512 1000 mg IV Q2W. |
| BG001 | PF-06730512 300 mg IV | Participants received PF-06730512 300 mg IV Q2W. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Full Analysis Set (FAS) was defined as all enrolled participants who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collection. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure. | Posted | Least Squares Mean | 90% Confidence Interval | Percentage change | Baseline, Week 13 |
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| Secondary | 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. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. | Posted | Count of Participants | Participants | From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33) |
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| Secondary | 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. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows. | Posted | Count of Participants | Participants | From Day 1 of treatment up to Week 33 |
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| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight and at baseline values were reported for this outcome measure. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Mean | Standard Deviation | Kilogram | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
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| Secondary | Change From Baseline in Blood Pressure | Change from baseline in blood pressure and at baseline values were reported for this outcome measure. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Mean | Standard Deviation | Millimeter of mercury (mmHg) | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
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| Secondary | Change From Baseline in Pulse Rate | Change from baseline in pulse rate and at baseline values were reported for this outcome measure. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Mean | Standard Deviation | Beats per minute | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
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| Secondary | Change From Baseline in Body Temperature | Change from baseline in body temperature and at baseline values were reported for this outcome measure. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Mean | Standard Deviation | Degree Celsius | Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33 |
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| Secondary | 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. | SAS was defined as all enrolled participants who had received at least one dose of study treatment. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Count of Participants | Participants | Weeks 3, 7, 11, 13, 17, 21, 25, 33 |
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| Secondary | 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. | FAS was defined as all enrolled subjects who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collected. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Least Squares Mean | 90% Confidence Interval | Percent change | Baseline, Weeks 2, 5, 9 and 13 |
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| Secondary | 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. | FAS was defined as all enrolled subjects who had received at least one dose of study treatment and had at least one post-baseline measurement of UPCR based on 24-hour urine collected. Here, 'Number Analyzed' signifies number of participants evaluable for the specific timepoints. | Posted | Least Squares Mean | 90% Confidence Interval | Percent change | Baseline, Weeks 3, 5, 9 and 13 |
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| Secondary | Serum PF-06730512 Concentration Versus Time Summary | The PK concentration analysis set was defined as all enrolled participants treated who received at least one dose of PF-06730512 and had at least 1 measurable concentration. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows. | Posted | Mean | Standard Deviation | Microgram per milliliter | 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) |
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| Secondary | 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. | The immunogenicity analysis population included all treated participants with at least 1 ADA sample (pre-dose or post-treatment) analyzed. Participants those had only pre-dose baseline data and no post-treatment immunogenicity data, was not evaluated for subject-level ADA and NAb status. Here, 'Number Analyzed' signifies number of participants evaluable for the specific rows. | Posted | Count of Participants | Participants | From Day 1 of treatment up to Week 33 |
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From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)
Same event may appear as both non-SAE and a serious AE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participants, or one participant may have experienced both a serious and non-serious event during the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PF-06730512 1000 mg IV | Participants received PF-06730512 1000 mg IV Q2W. | 0 | 23 | 2 | 23 | 11 | 23 |
| EG001 | PF-06730512 300 mg IV | Participants received PF-06730512 300 mg IV Q2W. | 0 | 24 | 2 | 24 | 12 | 24 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Disease progression | General disorders | MedDRA v25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Hypervolaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Acute kidney injury | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Renal impairment | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Oedema | General disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Viral infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
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| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
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| SARS-CoV-2 test positive | Investigations | MedDRA v25.1 | Non-systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Flank pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Insomnia | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
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Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 23, 2023 | Feb 1, 2024 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D005923 | Glomerulosclerosis, Focal Segmental |
| D011507 | Proteinuria |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C000722615 | PF-06730512 |
Not provided
Not provided
Not provided
| Physician's decision |
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| Study terminated by sponsor |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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Participants received PF-06730512 300 mg IV Q2W. |
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