A Phase 2 interventional study of PF-06730512 in Focal Segmental Glomerulosclerosis (FSGS), sponsored by Pfizer. Terminated at 110 sites in 12 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-18.
Sponsored by Pfizer · Phase 2, Interventional, and Treatment
Among 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States — 17 open to participants now, 20 under way, 2 of them phase 3. Glomerulosclerosis, Focal Segmental · United States.
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, this one is the 17th largest by enrollment of the 56 interventional ones, is one of 5 that started in 2018, is one of 29 in phase 2, and was the 33rd registered.
105 studies on the registry are indexed under Glomerulosclerosis, Focal Segmental; 33 are open to participants now.
This study's enrollment of 47 is above the median of 30 across 73 interventional studies indexed under Glomerulosclerosis, Focal Segmental.
Browse Glomerulosclerosis, Focal Segmental studies →17 of the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States are open now, in 12 countries. Each count lists the studies.
Of the 30 Glomerulosclerosis, Focal Segmental studies recruiting now, 11 (37%) set no upper age limit and 12 (40%) stop at 75 or younger; 22 take children under 18; 2 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →68 studies; the count open now beside each. This study's row is marked.
First in 1996; this study’s year is marked. 5 started in 2018.
Median enrollment 30 across the 56 interventional studies, 201 across the 12 observational. Of the 45 that completed or were terminated, 23 (51%) have results posted.
33 of 68 have an industry lead sponsor. The 10 most frequent:
Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Pfizer has 1 study filed under Glomerulosclerosis, Focal Segmental — fewer than ten, so there is no comparison to draw.
10 of the studies in Glomerulosclerosis, Focal Segmental with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT01094327University of MiamiProteinuria in Pre and Post Transplant | 2026-11-30 |
| NCT06500702SanofiA Study to Evaluate the Efficacy and Safety of Frexalimab, Brivekimig, or Rilzabrutinib in Participants Aged 16 to 75 Years With Primary Focal Segmental Glomerulosclerosis or Minimal Change Disease | 2026-12-23 |
| NCT07219121Travere Therapeutics, Inc.Sparsentan in Posttransplant Immunoglobulin A Nephropathy or Focal Segmental Glomerulosclerosis | 2027-03 |
| NCT05583942Northwell HealthA Pilot Trial of taVNS for SRNS in Children (kidNEY-VNS) | 2027-03-01 |
| NCT05588063Northwell HealthtaVNS for FRNS in Children | 2027-03-01 |
Among the 68 studies in Glomerulosclerosis, Focal Segmental with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects in cohort 1 will receive dose 1 Intravenous (IV) infusion.
Drug: PF-06730512
Subjects in cohort 2 will receive dose 2 IV infusion.
Drug: PF-06730512
Subjects in cohort 3 will receive dose 3 IV infusion.
Drug: PF-06730512
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.
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.
Time frame: Baseline, Week 13
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.
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
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.
Time frame: 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.
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 Blood Pressure
Change from baseline in blood pressure and at baseline values were reported for this outcome measure.
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
Change from baseline in pulse rate and at baseline values were reported for this outcome measure.
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 Body Temperature
Change from baseline in body temperature and at baseline values were reported for this outcome measure.
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 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, Weeks 3, 5, 9 and 13
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 Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)
Number of participants with positive ADA and/or NAb were reported for this outcome measure.
Time frame: From Day 1 of treatment up to Week 33
| Milestone | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Started | 23 | 24 |
| Completed | 23 | 24 |
| Not completed | 0 | 0 |
| Milestone | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Started | 23 | 24 |
| Completed | 23 | 24 |
| Not completed | 0 | 0 |
| Milestone | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Started | 23 | 24 |
| Completed | 22 | 15 |
| Not completed | 1 | 9 |
| Withdrew: Adverse event | 1 | 0 |
| Withdrew: Lack of efficacy | 0 | 1 |
| Withdrew: Physician's decision | 0 | 1 |
| Withdrew: Study terminated by sponsor | 0 | 5 |
| Withdrew: Withdrawal by subject | 0 | 2 |
| Milestone | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
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.
| Percentage change | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13 | -12.283 (-26.096 to 4.112) | -0.045 (-9.528 to 10.432) |
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.
| Participants | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 20 | 17 |
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.
| Participants | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Hematology: Hemoglobin < 0.8 * Lower Limit Number (LLN) | 5 | 4 |
| Hematology: Hematocrit < 0.8 * LLN | 5 | 7 |
| Hematology: Erythrocytes < 0.8 * LLN | 3 | 4 |
| Hematology: Ery. Mean Corpuscular Volume < 0.9 * LLN | 1 | 0 |
| Hematology: Ery. Mean Corpuscular Hemoglobin < 0.9 * LLN | 1 | 0 |
| Hematology: Platelets> 1.75 * ULN | 1 | 0 |
| Hematology: Lymphocytes< 0.8 * LLN | 0 | 4 |
| Hematology: Lymphocytes/Leukocytes < 0.8 * LLN | 1 | 6 |
| Hematology: Lymphocytes/Leukocytes > 1.2 * ULN | 0 | 1 |
| Hematology: Neutrophils < 0.8 * LLN | 1 | 2 |
| Hematology: Neutrophils > 1.2 * ULN | 3 | 4 |
| Hematology: Neutrophils/Leukocytes < 0.8 * LLN | 1 | 1 |
| Hematology: Neutrophils/Leukocytes > 1.2 * ULN | 0 | 1 |
| Hematology: Eosinophils > 1.2 * ULN | 2 | 1 |
| Hematology: Eosinophils/Leukocytes> 1.2 * ULN | 3 | 3 |
| Hematology: Monocytes/Leukocytes> 1.2 * ULN | 0 | 1 |
| Clinical chemistry: Aspartate Aminotransferase > 3.0 * ULN | 1 | 0 |
| Clinical chemistry: Alanine Aminotransferase > 3.0 * ULN | 1 | 0 |
| Clinical chemistry: Protein < 0.8 * LLN | 9 | 11 |
| Clinical chemistry: Albumin < 0.8 * LLN | 8 | 11 |
| Clinical chemistry: Blood Urea Nitrogen > 1.3 * ULN | 10 | 8 |
| Clinical chemistry: Creatinine > 1.3 * ULN | 8 | 12 |
| Clinical chemistry: Urate > 1.2 * ULN | 3 | 2 |
| Clinical chemistry: Cholesterol > 1.3 * ULN | 6 | 7 |
| Clinical chemistry: HDL Cholesterol < 0.8 * LLN | 1 | 0 |
| Clinical chemistry: LDL Cholesterol > 1.2 * ULN | 6 | 5 |
| Clinical chemistry: Triglycerides > 1.3 * ULN | 6 | 8 |
| Clinical chemistry: Sodium < 0.95 * LLN | 1 | 0 |
| Clinical chemistry: Potassium < 0.9 * LLN | 1 | 0 |
| Clinical chemistry: Potassium > 1.1 * ULN | 1 | 0 |
| Clinical chemistry: Calcium < 0.9 * LLN | 1 | 3 |
| Clinical chemistry: Bicarbonate < 0.9 * LLN | 0 | 1 |
| Clinical chemistry: Glucose > 1.5 * ULN | 2 | 2 |
| Urinalysis: Specific Gravity > 1.030 | 5 | 6 |
| Urinalysis: pH > 8 | 1 | 0 |
| Urinalysis: Urine Glucose >= 1 | 5 | 10 |
| Urinalysis: Urine Protein >=1 | 22 | 24 |
| Urinalysis: Urine Hemoglobin >=1 | 15 | 17 |
| Urinalysis: Nitrite >= 1 | 1 | 3 |
| Urinalysis: Leukocyte Esterase >= 1 | 5 | 6 |
| Urinalysis: Urine Erythrocytes >= 20 | 3 | 3 |
| Urinalysis: Urine Leukocytes >= 20 | 2 | 5 |
| Urinalysis: Granular Casts > 1 | 4 | 2 |
| Urinalysis: Hyaline Casts > 1 | 17 | 15 |
| Urinalysis: Urine Creatinine <40 | 9 | 8 |
| Urinalysis: Urine Creatinine >300 | 1 | 0 |
| Urinalysis: Urine (24HR) Creatinine > 1.1 * ULN | 2 | 6 |
Change from baseline in body weight and at baseline values were reported for this outcome measure.
| Kilogram | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Baseline | 78.3 ± 17.8 | 88.9 ± 23.5 |
| Week 2 | 1.0 ± 2.2 | -0.3 ± 1.9 |
| Week 3 | 0.4 ± 2.5 | -0.3 ± 2.2 |
| Week 5 | 0.5 ± 3.0 | -0.5 ± 4.8 |
| Week 7 | 0.6 ± 2.6 | -1.0 ± 5.3 |
| Week 9 | 0.1 ± 3.1 | -0.4 ± 3.4 |
| Week 11 | 0.7 ± 2.8 | -0.1 ± 4.2 |
| Week 13 | -0.2 ± 1.9 | -1.0 ± 3.4 |
| Week15 | -0.3 ± 1.0 | -0.7 ± 4.0 |
| Week 17 | -0.2 ± 1.2 | -1.2 ± 4.8 |
| Week 19 | -0.4 ± 1.0 | -1.3 ± 4.8 |
| Week 21 | 0.3 ± 1.7 | -1.3 ± 4.9 |
| Week 23 | 0.3 ± 1.2 | -1.5 ± 5.3 |
| Week 25 | -0.1 ± 1.6 | -1.1 ± 4.8 |
| Week 27 | 0.7 ± 1.4 | -0.6 ± 5.2 |
| Week 29 | 0.5 ± 1.5 | -1.0 ± 4.5 |
| Week 33 | 0.5 ± 1.6 | -0.6 ± 5.4 |
Change from baseline in blood pressure and at baseline values were reported for this outcome measure.
| Millimeter of mercury (mmHg) | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Baseline | 131.2 ± 12.8 | 125.3 ± 11.8 |
| Week 2 | -1.8 ± 13.1 | -1.3 ± 7.8 |
| Week 3 | -1.3 ± 10.2 | 1.7 ± 7.5 |
| Week 5 | -3.0 ± 10.6 | -1.9 ± 9.0 |
| Week 7 | -2.0 ± 11.3 | -1.2 ± 9.0 |
| Week 9 | -5.1 ± 10.7 | -2.6 ± 7.6 |
| Week 11 | -1.5 ± 12.5 | -1.6 ± 6.1 |
| Week 13 | -2.0 ± 11.3 | -1.0 ± 10.0 |
| Week15 | -7.5 ± 5.1 | -2.3 ± 6.2 |
| Week 17 | -7.3 ± 12.7 | -7.7 ± 12.2 |
| Week 19 | -8.0 ± 8.4 | 0.4 ± 10.7 |
| Week 21 | -8.0 ± 16.4 | -5.8 ± 10.1 |
| Week 23 | 1.0 ± 9.0 | -3.6 ± 8.2 |
| Week 25 | -9.0 ± 13.2 | -2.6 ± 11.2 |
| Week 27 | -3.0 ± 10.4 | 3.5 ± 10.5 |
| Week 29 | -8.3 ± 8.4 | 0.4 ± 11.2 |
| Week 33 | -12.0 ± 20.7 | 4.6 ± 8.9 |
Change from baseline in pulse rate and at baseline values were reported for this outcome measure.
| Beats per minute | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Baseline | 74.1 ± 11.8 | 74.2 ± 11.0 |
| Week 2 | 2.1 ± 9.6 | 0.6 ± 6.9 |
| Week 3 | -0.6 ± 8.0 | -1.1 ± 6.0 |
| Week 5 | 0.0 ± 7.3 | -0.3 ± 8.0 |
| Week 7 | -0.3 ± 9.2 | 0.0 ± 7.9 |
| Week 9 | -1.0 ± 11.1 | 1.5 ± 9.0 |
| Week 11 | -1.7 ± 10.8 | 0.6 ± 6.6 |
| Week 13 | 3.3 ± 11.9 | 0.5 ± 6.9 |
| Week15 | -5.8 ± 10.4 | 5.0 ± 10.1 |
| Week 17 | -6.3 ± 8.8 | -2.2 ± 5.0 |
| Week 19 | -3.5 ± 13.7 | 2.9 ± 6.5 |
| Week 21 | -5.5 ± 12.8 | -1.6 ± 5.0 |
| Week 23 | -3.3 ± 10.5 | -3.1 ± 9.0 |
| Week 25 | -6.3 ± 12.5 | 1.8 ± 7.6 |
| Week 27 | -0.8 ± 16.0 | 2.9 ± 7.2 |
| Week 29 | 2.5 ± 14.8 | 5.9 ± 8.8 |
| Week 33 | -0.5 ± 15.3 | 6.2 ± 10.0 |
Change from baseline in body temperature and at baseline values were reported for this outcome measure.
| Degree Celsius | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Baseline | 36.4 ± 0.4 | 36.6 ± 0.2 |
| Week 2 | 0.1 ± 0.4 | -0.0 ± 0.3 |
| Week 3 | 0.0 ± 0.2 | -0.1 ± 0.3 |
| Week 5 | 0.0 ± 0.4 | -0.1 ± 0.3 |
| Week 7 | 0.1 ± 0.3 | -0.0 ± 0.3 |
| Week 9 | 0.0 ± 0.4 | -0.1 ± 0.3 |
| Week 11 | 0.1 ± 0.3 | -0.0 ± 0.3 |
| Week 13 | -0.1 ± 0.4 | -0.0 ± 0.2 |
| Week 15 | 0.2 ± 0.2 | 0.1 ± 0.2 |
| Week 17 | 0.1 ± 0.2 | 0.1 ± 0.2 |
| Week 19 | 0.1 ± 0.4 | 0.1 ± 0.3 |
| Week 21 | -0.0 ± 0.1 | -0.1 ± 0.5 |
| Week 23 | 0.2 ± 0.2 | 0.0 ± 0.3 |
| Week 25 | 0.1 ± 0.2 | 0.0 ± 0.2 |
| Week 27 | 0.1 ± 0.1 | 0.1 ± 0.2 |
| Week 29 | 0.1 ± 0.3 | -0.1 ± 0.4 |
| Week 33 | 0.1 ± 0.1 | -0.1 ± 0.3 |
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.
| Participants | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Week 3 (Not Clinically Significant) | 3 | 4 |
| Week 3 (Clinically Significant) | 1 | 0 |
| Week 7 (Not Clinically Significant) | 3 | 4 |
| Week 7 (Clinically Significant) | 0 | 0 |
| Week 11 (Not Clinically Significant) | 4 | 4 |
| Week 11 (Clinically Significant) | 1 | 0 |
| Week 13 (Not Clinically Significant) | 6 | 4 |
| Week 13 (Clinically Significant) | 1 | 0 |
| Week 17 (Not Clinically Significant) | 0 | 0 |
| Week 17 (Clinically Significant) | 0 | 0 |
| Week 21 (Not Clinically Significant) | 1 | 1 |
| Week 21 (Clinically Significant) | 0 | 0 |
| Week 25 (Not Clinically Significant) | 1 | 1 |
| Week 25 (Clinically Significant) | 0 | 0 |
| Week 33 (Not Clinically Significant) | 0 | 2 |
| Week 33 (Clinically Significant) | 0 | 0 |
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.
| Percent change | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Week 5 | 6.250 (-7.035 to 21.433) | -3.788 (-11.344 to 4.411) |
| Week 9 | -11.335 (-20.746 to -0.807) | -2.354 (-11.069 to 7.215) |
| Week 13 | -12.283 (-26.096 to 4.112) | -0.045 (-9.528 to 10.432) |
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.
| Percent change | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Week 3 | 5.657 (-0.722 to 12.446) | -0.180 (-4.179 to 3.987) |
| Week 5 | 2.174 (-3.012 to 7.637) | -2.038 (-8.008 to 4.319) |
| Week 9 | -1.536 (-15.575 to 14.838) | -5.017 (-11.596 to 2.052) |
| Week 13 | 2.892 (-6.096 to 12.740) | -12.217 (-18.831 to -5.063) |
| Microgram per milliliter | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| Day 1: Pre-dose (12,24WT) | 0 ± 0 | 0 ± 0 |
| Day 1: Post-dose (12,24WT) | 279.4 ± 86.548 | 71.94 ± 29.668 |
| Day 8: Pre-dose (12,24WT) | 39.50 ± NA | 13.09 ± 6.9363 |
| Day 15: Pre-dose (12,24WT) | 16.45 ± 11.266 | 5.096 ± 3.1184 |
| Day 29: Pre-dose (12,24WT) | 24.92 ± 20.256 | 6.916 ± 5.0154 |
| Day 43: Pre-dose (12,24WT) | 29.96 ± 22.062 | 6.991 ± 5.5862 |
| Day 57: Pre-dose (12,24WT) | 32.56 ± 23.031 | 7.664 ± 6.1325 |
| Day 71: Pre-dose (12,24WT) | 27.32 ± 16.688 | 6.736 ± 5.6237 |
| Day 71: Post-dose(12,24WT) | 298.6 ± 208.87 | 129.2 ± 201.50 |
| Day 85: Pre-dose (24WT) | 41.15 ± 23.516 | 7.597 ± 6.9184 |
| Day 85/Fup (12 WT) | 27.19 ± 21.589 | 6.884 ± 7.1511 |
| Day 99/Fup (12 WT) | 11.50 ± 12.948 | 2.313 ± 3.1827 |
| Day 113/Fup (12 WT) | 4.991 ± 6.1121 | 0.6356 ± 0.81118 |
| Day 141/Fup (12 WT) | 1.385 ± 2.1196 | 0.1438 ± 0.21666 |
| Day 99: Pre-dose (24WT) | 35.65 ± 16.065 | 7.084 ± 6.9224 |
| Day 113: Pre-dose (24WT) | 42.40 ± 25.049 | 9.442 ± 8.6965 |
| Day 127: Pre-dose (24WT) | 30.67 ± 5.3463 | 6.732 ± 5.2295 |
| Day 141: Pre-dose (24WT) | 38.00 ± 13.880 | 8.957 ± 10.753 |
| Day 155: Pre-dose (24WT) | 32.57 ± 5.8287 | 7.585 ± 8.1601 |
| Day 155: Post-dose (24WT) | 313.3 ± 63.793 | 62.71 ± 41.324 |
| Day 169: Pre-dose/Fup (24WT) | 29.32 ± 15.338 | 7.989 ± 7.4740 |
| Day 183/Fup (24WT) | 25.79 ± 30.417 | 3.046 ± 3.8895 |
| Day 197/Fup (24WT) | 6.108 ± 4.0049 | 1.048 ± 1.4978 |
| Day 225/Fup (24WT) | 2.009 ± 1.6808 | 0.2659 ± 0.45714 |
Number of participants with positive ADA and/or NAb were reported for this outcome measure.
| Participants | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| ADA Positive | 1 | 0 |
| nAb Positive | 0 | 0 |
Collected over From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| PF-06730512 1000 mg IV | 0/23 (0%) | 2/23 (8.7%) | 11/23 (47.8%) |
| PF-06730512 300 mg IV | 0/24 (0%) | 2/24 (8.3%) | 12/24 (50%) |
| Event | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 1/23 | 0/24 |
| HypervolaemiaMetabolism and nutrition disorders | 1/23 | 0/24 |
| Acute kidney injuryRenal and urinary disorders | 1/23 | 0/24 |
| Renal impairmentRenal and urinary disorders | 1/23 | 0/24 |
| Disease progressionGeneral disorders | 0/23 | 1/24 |
| COVID-19Infections and infestations | 0/23 | 1/24 |
| Event | PF-06730512 1000 mg IV | PF-06730512 300 mg IV |
|---|---|---|
| FatigueGeneral disorders | 3/23 | 2/24 |
| HeadacheNervous system disorders | 2/23 | 3/24 |
| VomitingGastrointestinal disorders | 2/23 | 1/24 |
| PyrexiaGeneral disorders | 2/23 | 0/24 |
| Viral infectionInfections and infestations | 2/23 | 0/24 |
| SARS-CoV-2 test positiveInvestigations | 2/23 | 2/24 |
| DehydrationMetabolism and nutrition disorders | 2/23 | 0/24 |
| InsomniaPsychiatric disorders | 2/23 | 0/24 |
| CoughRespiratory, thoracic and mediastinal disorders | 2/23 | 0/24 |
| DiarrhoeaGastrointestinal disorders | 1/23 | 2/24 |
Safety Analysis Set (SAS) was defined as all enrolled participants who had received at least one dose of study treatment.
| Age, Continuous(Years) | PF-06730512 1000 mg IV | PF-06730512 300 mg IV | Total |
|---|---|---|---|
| Mean | 42.7 ± 13.64 | 41.0 ± 14.60 | 41.8 ± 14.01 |
| Sex: Female, Male(Participants) | PF-06730512 1000 mg IV | PF-06730512 300 mg IV | Total |
|---|---|---|---|
| Female | 12 | 10 | 22 |
| Male | 11 | 14 | 25 |
| Ethnicity (NIH/OMB)(Participants) | PF-06730512 1000 mg IV | PF-06730512 300 mg IV | Total |
|---|---|---|---|
| Hispanic or Latino | 5 | 3 | 8 |
| Not Hispanic or Latino | 18 | 21 | 39 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | PF-06730512 1000 mg IV | PF-06730512 300 mg IV | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 20 | 16 | 36 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
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PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
Data sharing details ↗ · www.pfizer.com
Ran from Oct 2018 to primary completion in Feb 2023, 51 months.
Results were first posted in Apr 2024, 1 year 2 months after primary completion.
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Glomerulosclerosis, Focal Segmental →