Trial Outcomes & Findings for A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS) (NCT NCT03448692)
NCT ID: NCT03448692
Last Updated: 2024-04-18
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline, Week 13
Results posted on
2024-04-18
Participant Flow
A total of 47 participants were enrolled into the study. All participants received treatment.
Participant milestones
| Measure |
PF-06730512 1000 mg IV
Participants received PF-06730512 1000 milligram (mg) intravenously (IV) every 2 weeks (Q2W).
|
PF-06730512 300 mg IV
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Disposition Phase:Screening:up to 43Days
STARTED
|
23
|
24
|
|
Disposition Phase:Screening:up to 43Days
COMPLETED
|
23
|
24
|
|
Disposition Phase:Screening:up to 43Days
NOT COMPLETED
|
0
|
0
|
|
Lead in Period:8 Weeks (W)
STARTED
|
23
|
24
|
|
Lead in Period:8 Weeks (W)
COMPLETED
|
23
|
24
|
|
Lead in Period:8 Weeks (W)
NOT COMPLETED
|
0
|
0
|
|
Investigational Treatment Period:Upto24W
STARTED
|
23
|
24
|
|
Investigational Treatment Period:Upto24W
COMPLETED
|
22
|
15
|
|
Investigational Treatment Period:Upto24W
NOT COMPLETED
|
1
|
9
|
|
Follow up Period:9 Weeks
STARTED
|
23
|
23
|
|
Follow up Period:9 Weeks
COMPLETED
|
23
|
23
|
|
Follow up Period:9 Weeks
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
| Measure |
PF-06730512 1000 mg IV
Participants received PF-06730512 1000 milligram (mg) intravenously (IV) every 2 weeks (Q2W).
|
PF-06730512 300 mg IV
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Investigational Treatment Period:Upto24W
Adverse Event
|
1
|
0
|
|
Investigational Treatment Period:Upto24W
Lack of Efficacy
|
0
|
1
|
|
Investigational Treatment Period:Upto24W
Physician's decision
|
0
|
1
|
|
Investigational Treatment Period:Upto24W
Study terminated by sponsor
|
0
|
5
|
|
Investigational Treatment Period:Upto24W
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate PF-06730512 in Adults With Focal Segmental Glomerulosclerosis (FSGS)
Baseline characteristics by cohort
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
42.7 Years
STANDARD_DEVIATION 13.64 • n=5 Participants
|
41.0 Years
STANDARD_DEVIATION 14.60 • n=7 Participants
|
41.8 Years
STANDARD_DEVIATION 14.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 13Population: 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.
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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=21 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=19 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) Based on 24-hour Urine Collection at Week 13
|
-12.283 Percentage change
Interval -26.096 to 4.112
|
-0.045 Percentage change
Interval -9.528 to 10.432
|
SECONDARY outcome
Timeframe: From Day 1 of treatment up to 9 weeks after last dose of study treatment (up to Week 33)Population: SAS was defined as all enrolled participants who had received at least one dose of study treatment.
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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
|
20 Participants
|
17 Participants
|
SECONDARY outcome
Timeframe: From Day 1 of treatment up to Week 33Population: 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.
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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Monocytes/Leukocytes> 1.2 * ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Urate > 1.2 * ULN
|
3 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Cholesterol > 1.3 * ULN
|
6 Participants
|
7 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Nitrite >= 1
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Leukocyte Esterase >= 1
|
5 Participants
|
6 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Leukocytes >= 20
|
2 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Granular Casts > 1
|
4 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Creatinine <40
|
9 Participants
|
8 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine (24HR) Creatinine > 1.1 * ULN
|
2 Participants
|
6 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Blood Urea Nitrogen > 1.3 * ULN
|
10 Participants
|
8 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Creatinine > 1.3 * ULN
|
8 Participants
|
12 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Hemoglobin < 0.8 * Lower Limit Number (LLN)
|
5 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Hematocrit < 0.8 * LLN
|
5 Participants
|
7 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Erythrocytes < 0.8 * LLN
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Ery. Mean Corpuscular Volume < 0.9 * LLN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Ery. Mean Corpuscular Hemoglobin < 0.9 * LLN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Platelets> 1.75 * ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Lymphocytes< 0.8 * LLN
|
0 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Lymphocytes/Leukocytes < 0.8 * LLN
|
1 Participants
|
6 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Lymphocytes/Leukocytes > 1.2 * ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Neutrophils < 0.8 * LLN
|
1 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Neutrophils > 1.2 * ULN
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Neutrophils/Leukocytes < 0.8 * LLN
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Neutrophils/Leukocytes > 1.2 * ULN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Eosinophils > 1.2 * ULN
|
2 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Hematology: Eosinophils/Leukocytes> 1.2 * ULN
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Aspartate Aminotransferase > 3.0 * ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Alanine Aminotransferase > 3.0 * ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Protein < 0.8 * LLN
|
9 Participants
|
11 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Albumin < 0.8 * LLN
|
8 Participants
|
11 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: HDL Cholesterol < 0.8 * LLN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: LDL Cholesterol > 1.2 * ULN
|
6 Participants
|
5 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Triglycerides > 1.3 * ULN
|
6 Participants
|
8 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Sodium < 0.95 * LLN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Potassium < 0.9 * LLN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Potassium > 1.1 * ULN
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Calcium < 0.9 * LLN
|
1 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Bicarbonate < 0.9 * LLN
|
0 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Clinical chemistry: Glucose > 1.5 * ULN
|
2 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Specific Gravity > 1.030
|
5 Participants
|
6 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: pH > 8
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Glucose >= 1
|
5 Participants
|
10 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Protein >=1
|
22 Participants
|
24 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Hemoglobin >=1
|
15 Participants
|
17 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Erythrocytes >= 20
|
3 Participants
|
3 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Hyaline Casts > 1
|
17 Participants
|
15 Participants
|
|
Number of Participants With Abnormalities in Laboratory Test Parameters
Urinalysis: Urine Creatinine >300
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Population: 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.
Change from baseline in body weight and at baseline values were reported for this outcome measure.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Change From Baseline in Body Weight
Week 17
|
-0.2 Kilogram
Standard Deviation 1.2
|
-1.2 Kilogram
Standard Deviation 4.8
|
|
Change From Baseline in Body Weight
Week 19
|
-0.4 Kilogram
Standard Deviation 1.0
|
-1.3 Kilogram
Standard Deviation 4.8
|
|
Change From Baseline in Body Weight
Baseline
|
78.3 Kilogram
Standard Deviation 17.8
|
88.9 Kilogram
Standard Deviation 23.5
|
|
Change From Baseline in Body Weight
Week 2
|
1.0 Kilogram
Standard Deviation 2.2
|
-0.3 Kilogram
Standard Deviation 1.9
|
|
Change From Baseline in Body Weight
Week 3
|
0.4 Kilogram
Standard Deviation 2.5
|
-0.3 Kilogram
Standard Deviation 2.2
|
|
Change From Baseline in Body Weight
Week 5
|
0.5 Kilogram
Standard Deviation 3.0
|
-0.5 Kilogram
Standard Deviation 4.8
|
|
Change From Baseline in Body Weight
Week 7
|
0.6 Kilogram
Standard Deviation 2.6
|
-1.0 Kilogram
Standard Deviation 5.3
|
|
Change From Baseline in Body Weight
Week 9
|
0.1 Kilogram
Standard Deviation 3.1
|
-0.4 Kilogram
Standard Deviation 3.4
|
|
Change From Baseline in Body Weight
Week 11
|
0.7 Kilogram
Standard Deviation 2.8
|
-0.1 Kilogram
Standard Deviation 4.2
|
|
Change From Baseline in Body Weight
Week 13
|
-0.2 Kilogram
Standard Deviation 1.9
|
-1.0 Kilogram
Standard Deviation 3.4
|
|
Change From Baseline in Body Weight
Week15
|
-0.3 Kilogram
Standard Deviation 1.0
|
-0.7 Kilogram
Standard Deviation 4.0
|
|
Change From Baseline in Body Weight
Week 21
|
0.3 Kilogram
Standard Deviation 1.7
|
-1.3 Kilogram
Standard Deviation 4.9
|
|
Change From Baseline in Body Weight
Week 23
|
0.3 Kilogram
Standard Deviation 1.2
|
-1.5 Kilogram
Standard Deviation 5.3
|
|
Change From Baseline in Body Weight
Week 25
|
-0.1 Kilogram
Standard Deviation 1.6
|
-1.1 Kilogram
Standard Deviation 4.8
|
|
Change From Baseline in Body Weight
Week 27
|
0.7 Kilogram
Standard Deviation 1.4
|
-0.6 Kilogram
Standard Deviation 5.2
|
|
Change From Baseline in Body Weight
Week 29
|
0.5 Kilogram
Standard Deviation 1.5
|
-1.0 Kilogram
Standard Deviation 4.5
|
|
Change From Baseline in Body Weight
Week 33
|
0.5 Kilogram
Standard Deviation 1.6
|
-0.6 Kilogram
Standard Deviation 5.4
|
SECONDARY outcome
Timeframe: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Population: 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.
Change from baseline in blood pressure and at baseline values were reported for this outcome measure.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Change From Baseline in Blood Pressure
Baseline
|
131.2 Millimeter of mercury (mmHg)
Standard Deviation 12.8
|
125.3 Millimeter of mercury (mmHg)
Standard Deviation 11.8
|
|
Change From Baseline in Blood Pressure
Week 2
|
-1.8 Millimeter of mercury (mmHg)
Standard Deviation 13.1
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 7.8
|
|
Change From Baseline in Blood Pressure
Week 3
|
-1.3 Millimeter of mercury (mmHg)
Standard Deviation 10.2
|
1.7 Millimeter of mercury (mmHg)
Standard Deviation 7.5
|
|
Change From Baseline in Blood Pressure
Week 5
|
-3.0 Millimeter of mercury (mmHg)
Standard Deviation 10.6
|
-1.9 Millimeter of mercury (mmHg)
Standard Deviation 9.0
|
|
Change From Baseline in Blood Pressure
Week 7
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 11.3
|
-1.2 Millimeter of mercury (mmHg)
Standard Deviation 9.0
|
|
Change From Baseline in Blood Pressure
Week 9
|
-5.1 Millimeter of mercury (mmHg)
Standard Deviation 10.7
|
-2.6 Millimeter of mercury (mmHg)
Standard Deviation 7.6
|
|
Change From Baseline in Blood Pressure
Week 11
|
-1.5 Millimeter of mercury (mmHg)
Standard Deviation 12.5
|
-1.6 Millimeter of mercury (mmHg)
Standard Deviation 6.1
|
|
Change From Baseline in Blood Pressure
Week 13
|
-2.0 Millimeter of mercury (mmHg)
Standard Deviation 11.3
|
-1.0 Millimeter of mercury (mmHg)
Standard Deviation 10.0
|
|
Change From Baseline in Blood Pressure
Week15
|
-7.5 Millimeter of mercury (mmHg)
Standard Deviation 5.1
|
-2.3 Millimeter of mercury (mmHg)
Standard Deviation 6.2
|
|
Change From Baseline in Blood Pressure
Week 17
|
-7.3 Millimeter of mercury (mmHg)
Standard Deviation 12.7
|
-7.7 Millimeter of mercury (mmHg)
Standard Deviation 12.2
|
|
Change From Baseline in Blood Pressure
Week 19
|
-8.0 Millimeter of mercury (mmHg)
Standard Deviation 8.4
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 10.7
|
|
Change From Baseline in Blood Pressure
Week 21
|
-8.0 Millimeter of mercury (mmHg)
Standard Deviation 16.4
|
-5.8 Millimeter of mercury (mmHg)
Standard Deviation 10.1
|
|
Change From Baseline in Blood Pressure
Week 23
|
1.0 Millimeter of mercury (mmHg)
Standard Deviation 9.0
|
-3.6 Millimeter of mercury (mmHg)
Standard Deviation 8.2
|
|
Change From Baseline in Blood Pressure
Week 25
|
-9.0 Millimeter of mercury (mmHg)
Standard Deviation 13.2
|
-2.6 Millimeter of mercury (mmHg)
Standard Deviation 11.2
|
|
Change From Baseline in Blood Pressure
Week 27
|
-3.0 Millimeter of mercury (mmHg)
Standard Deviation 10.4
|
3.5 Millimeter of mercury (mmHg)
Standard Deviation 10.5
|
|
Change From Baseline in Blood Pressure
Week 29
|
-8.3 Millimeter of mercury (mmHg)
Standard Deviation 8.4
|
0.4 Millimeter of mercury (mmHg)
Standard Deviation 11.2
|
|
Change From Baseline in Blood Pressure
Week 33
|
-12.0 Millimeter of mercury (mmHg)
Standard Deviation 20.7
|
4.6 Millimeter of mercury (mmHg)
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Population: 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.
Change from baseline in pulse rate and at baseline values were reported for this outcome measure.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Change From Baseline in Pulse Rate
Baseline
|
74.1 Beats per minute
Standard Deviation 11.8
|
74.2 Beats per minute
Standard Deviation 11.0
|
|
Change From Baseline in Pulse Rate
Week 2
|
2.1 Beats per minute
Standard Deviation 9.6
|
0.6 Beats per minute
Standard Deviation 6.9
|
|
Change From Baseline in Pulse Rate
Week 3
|
-0.6 Beats per minute
Standard Deviation 8.0
|
-1.1 Beats per minute
Standard Deviation 6.0
|
|
Change From Baseline in Pulse Rate
Week 5
|
0.0 Beats per minute
Standard Deviation 7.3
|
-0.3 Beats per minute
Standard Deviation 8.0
|
|
Change From Baseline in Pulse Rate
Week 7
|
-0.3 Beats per minute
Standard Deviation 9.2
|
0.0 Beats per minute
Standard Deviation 7.9
|
|
Change From Baseline in Pulse Rate
Week 9
|
-1.0 Beats per minute
Standard Deviation 11.1
|
1.5 Beats per minute
Standard Deviation 9.0
|
|
Change From Baseline in Pulse Rate
Week 11
|
-1.7 Beats per minute
Standard Deviation 10.8
|
0.6 Beats per minute
Standard Deviation 6.6
|
|
Change From Baseline in Pulse Rate
Week 13
|
3.3 Beats per minute
Standard Deviation 11.9
|
0.5 Beats per minute
Standard Deviation 6.9
|
|
Change From Baseline in Pulse Rate
Week15
|
-5.8 Beats per minute
Standard Deviation 10.4
|
5.0 Beats per minute
Standard Deviation 10.1
|
|
Change From Baseline in Pulse Rate
Week 17
|
-6.3 Beats per minute
Standard Deviation 8.8
|
-2.2 Beats per minute
Standard Deviation 5.0
|
|
Change From Baseline in Pulse Rate
Week 19
|
-3.5 Beats per minute
Standard Deviation 13.7
|
2.9 Beats per minute
Standard Deviation 6.5
|
|
Change From Baseline in Pulse Rate
Week 21
|
-5.5 Beats per minute
Standard Deviation 12.8
|
-1.6 Beats per minute
Standard Deviation 5.0
|
|
Change From Baseline in Pulse Rate
Week 23
|
-3.3 Beats per minute
Standard Deviation 10.5
|
-3.1 Beats per minute
Standard Deviation 9.0
|
|
Change From Baseline in Pulse Rate
Week 25
|
-6.3 Beats per minute
Standard Deviation 12.5
|
1.8 Beats per minute
Standard Deviation 7.6
|
|
Change From Baseline in Pulse Rate
Week 27
|
-0.8 Beats per minute
Standard Deviation 16.0
|
2.9 Beats per minute
Standard Deviation 7.2
|
|
Change From Baseline in Pulse Rate
Week 29
|
2.5 Beats per minute
Standard Deviation 14.8
|
5.9 Beats per minute
Standard Deviation 8.8
|
|
Change From Baseline in Pulse Rate
Week 33
|
-0.5 Beats per minute
Standard Deviation 15.3
|
6.2 Beats per minute
Standard Deviation 10.0
|
SECONDARY outcome
Timeframe: Baseline, Change at Weeks 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25, 27, 29, 33Population: 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.
Change from baseline in body temperature and at baseline values were reported for this outcome measure.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Change From Baseline in Body Temperature
Week 3
|
0.0 Degree Celsius
Standard Deviation 0.2
|
-0.1 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 5
|
0.0 Degree Celsius
Standard Deviation 0.4
|
-0.1 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 21
|
-0.0 Degree Celsius
Standard Deviation 0.1
|
-0.1 Degree Celsius
Standard Deviation 0.5
|
|
Change From Baseline in Body Temperature
Week 23
|
0.2 Degree Celsius
Standard Deviation 0.2
|
0.0 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Baseline
|
36.4 Degree Celsius
Standard Deviation 0.4
|
36.6 Degree Celsius
Standard Deviation 0.2
|
|
Change From Baseline in Body Temperature
Week 2
|
0.1 Degree Celsius
Standard Deviation 0.4
|
-0.0 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 7
|
0.1 Degree Celsius
Standard Deviation 0.3
|
-0.0 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 9
|
0.0 Degree Celsius
Standard Deviation 0.4
|
-0.1 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 11
|
0.1 Degree Celsius
Standard Deviation 0.3
|
-0.0 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 13
|
-0.1 Degree Celsius
Standard Deviation 0.4
|
-0.0 Degree Celsius
Standard Deviation 0.2
|
|
Change From Baseline in Body Temperature
Week 15
|
0.2 Degree Celsius
Standard Deviation 0.2
|
0.1 Degree Celsius
Standard Deviation 0.2
|
|
Change From Baseline in Body Temperature
Week 17
|
0.1 Degree Celsius
Standard Deviation 0.2
|
0.1 Degree Celsius
Standard Deviation 0.2
|
|
Change From Baseline in Body Temperature
Week 19
|
0.1 Degree Celsius
Standard Deviation 0.4
|
0.1 Degree Celsius
Standard Deviation 0.3
|
|
Change From Baseline in Body Temperature
Week 25
|
0.1 Degree Celsius
Standard Deviation 0.2
|
0.0 Degree Celsius
Standard Deviation 0.2
|
|
Change From Baseline in Body Temperature
Week 27
|
0.1 Degree Celsius
Standard Deviation 0.1
|
0.1 Degree Celsius
Standard Deviation 0.2
|
|
Change From Baseline in Body Temperature
Week 29
|
0.1 Degree Celsius
Standard Deviation 0.3
|
-0.1 Degree Celsius
Standard Deviation 0.4
|
|
Change From Baseline in Body Temperature
Week 33
|
0.1 Degree Celsius
Standard Deviation 0.1
|
-0.1 Degree Celsius
Standard Deviation 0.3
|
SECONDARY outcome
Timeframe: Weeks 3, 7, 11, 13, 17, 21, 25, 33Population: 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.
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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 3 (Not Clinically Significant)
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 3 (Clinically Significant)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 7 (Not Clinically Significant)
|
3 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 7 (Clinically Significant)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 11 (Not Clinically Significant)
|
4 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 11 (Clinically Significant)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 13 (Not Clinically Significant)
|
6 Participants
|
4 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 13 (Clinically Significant)
|
1 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 17 (Not Clinically Significant)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 17 (Clinically Significant)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 21 (Not Clinically Significant)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 21 (Clinically Significant)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 25 (Not Clinically Significant)
|
1 Participants
|
1 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 25 (Clinically Significant)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 33 (Not Clinically Significant)
|
0 Participants
|
2 Participants
|
|
Number of Participants With Abnormalities in Electrocardiogram (ECG)
Week 33 (Clinically Significant)
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Weeks 2, 5, 9 and 13Population: 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.
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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13
Week 5
|
6.250 Percent change
Interval -7.035 to 21.433
|
-3.788 Percent change
Interval -11.344 to 4.411
|
|
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13
Week 9
|
-11.335 Percent change
Interval -20.746 to -0.807
|
-2.354 Percent change
Interval -11.069 to 7.215
|
|
Percentage Change From Baseline in Urinary Protein to Creatinine Ratio (UPCR) at Weeks 2, 5, 9 and 13
Week 13
|
-12.283 Percent change
Interval -26.096 to 4.112
|
-0.045 Percent change
Interval -9.528 to 10.432
|
SECONDARY outcome
Timeframe: Baseline, Weeks 3, 5, 9 and 13Population: 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.
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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13
Week 3
|
5.657 Percent change
Interval -0.722 to 12.446
|
-0.180 Percent change
Interval -4.179 to 3.987
|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13
Week 5
|
2.174 Percent change
Interval -3.012 to 7.637
|
-2.038 Percent change
Interval -8.008 to 4.319
|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13
Week 9
|
-1.536 Percent change
Interval -15.575 to 14.838
|
-5.017 Percent change
Interval -11.596 to 2.052
|
|
Percentage Change From Baseline in Estimated Glomerular Filtration Rate (eGFR ) at Weeks 3, 5, 9 and 13
Week 13
|
2.892 Percent change
Interval -6.096 to 12.74
|
-12.217 Percent change
Interval -18.831 to -5.063
|
SECONDARY outcome
Timeframe: 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)Population: 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.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 1: Pre-dose (12,24WT)
|
0 Microgram per milliliter
Standard Deviation 0
|
0 Microgram per milliliter
Standard Deviation 0
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 155: Pre-dose (24WT)
|
32.57 Microgram per milliliter
Standard Deviation 5.8287
|
7.585 Microgram per milliliter
Standard Deviation 8.1601
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 155: Post-dose (24WT)
|
313.3 Microgram per milliliter
Standard Deviation 63.793
|
62.71 Microgram per milliliter
Standard Deviation 41.324
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 1: Post-dose (12,24WT)
|
279.4 Microgram per milliliter
Standard Deviation 86.548
|
71.94 Microgram per milliliter
Standard Deviation 29.668
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 8: Pre-dose (12,24WT)
|
39.50 Microgram per milliliter
Standard Deviation NA
Standard deviation could not be estimated as only one participant was evaluated.
|
13.09 Microgram per milliliter
Standard Deviation 6.9363
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 15: Pre-dose (12,24WT)
|
16.45 Microgram per milliliter
Standard Deviation 11.266
|
5.096 Microgram per milliliter
Standard Deviation 3.1184
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 29: Pre-dose (12,24WT)
|
24.92 Microgram per milliliter
Standard Deviation 20.256
|
6.916 Microgram per milliliter
Standard Deviation 5.0154
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 43: Pre-dose (12,24WT)
|
29.96 Microgram per milliliter
Standard Deviation 22.062
|
6.991 Microgram per milliliter
Standard Deviation 5.5862
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 57: Pre-dose (12,24WT)
|
32.56 Microgram per milliliter
Standard Deviation 23.031
|
7.664 Microgram per milliliter
Standard Deviation 6.1325
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 71: Pre-dose (12,24WT)
|
27.32 Microgram per milliliter
Standard Deviation 16.688
|
6.736 Microgram per milliliter
Standard Deviation 5.6237
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 71: Post-dose(12,24WT)
|
298.6 Microgram per milliliter
Standard Deviation 208.87
|
129.2 Microgram per milliliter
Standard Deviation 201.50
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 85: Pre-dose (24WT)
|
41.15 Microgram per milliliter
Standard Deviation 23.516
|
7.597 Microgram per milliliter
Standard Deviation 6.9184
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 85/Fup (12 WT)
|
27.19 Microgram per milliliter
Standard Deviation 21.589
|
6.884 Microgram per milliliter
Standard Deviation 7.1511
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 99/Fup (12 WT)
|
11.50 Microgram per milliliter
Standard Deviation 12.948
|
2.313 Microgram per milliliter
Standard Deviation 3.1827
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 113/Fup (12 WT)
|
4.991 Microgram per milliliter
Standard Deviation 6.1121
|
0.6356 Microgram per milliliter
Standard Deviation 0.81118
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 141/Fup (12 WT)
|
1.385 Microgram per milliliter
Standard Deviation 2.1196
|
0.1438 Microgram per milliliter
Standard Deviation 0.21666
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 99: Pre-dose (24WT)
|
35.65 Microgram per milliliter
Standard Deviation 16.065
|
7.084 Microgram per milliliter
Standard Deviation 6.9224
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 113: Pre-dose (24WT)
|
42.40 Microgram per milliliter
Standard Deviation 25.049
|
9.442 Microgram per milliliter
Standard Deviation 8.6965
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 127: Pre-dose (24WT)
|
30.67 Microgram per milliliter
Standard Deviation 5.3463
|
6.732 Microgram per milliliter
Standard Deviation 5.2295
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 141: Pre-dose (24WT)
|
38.00 Microgram per milliliter
Standard Deviation 13.880
|
8.957 Microgram per milliliter
Standard Deviation 10.753
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 169: Pre-dose/Fup (24WT)
|
29.32 Microgram per milliliter
Standard Deviation 15.338
|
7.989 Microgram per milliliter
Standard Deviation 7.4740
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 183/Fup (24WT)
|
25.79 Microgram per milliliter
Standard Deviation 30.417
|
3.046 Microgram per milliliter
Standard Deviation 3.8895
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 197/Fup (24WT)
|
6.108 Microgram per milliliter
Standard Deviation 4.0049
|
1.048 Microgram per milliliter
Standard Deviation 1.4978
|
|
Serum PF-06730512 Concentration Versus Time Summary
Day 225/Fup (24WT)
|
2.009 Microgram per milliliter
Standard Deviation 1.6808
|
0.2659 Microgram per milliliter
Standard Deviation 0.45714
|
SECONDARY outcome
Timeframe: From Day 1 of treatment up to Week 33Population: 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.
Number of participants with positive ADA and/or NAb were reported for this outcome measure.
Outcome measures
| Measure |
PF-06730512 1000 mg IV
n=23 Participants
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 Participants
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)
ADA Positive
|
1 Participants
|
0 Participants
|
|
Number of Participants With Positive Anti-Drug Antibody (ADA) and Neutralizing Antibody(NAb)
nAb Positive
|
0 Participants
|
0 Participants
|
Adverse Events
PF-06730512 1000 mg IV
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
PF-06730512 300 mg IV
Serious events: 2 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PF-06730512 1000 mg IV
n=23 participants at risk
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 participants at risk
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • 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.
|
0.00%
0/24 • 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.
|
|
General disorders
Disease progression
|
0.00%
0/23 • 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.
|
4.2%
1/24 • 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.
|
|
Infections and infestations
COVID-19
|
0.00%
0/23 • 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.
|
4.2%
1/24 • 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.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
4.3%
1/23 • 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.
|
0.00%
0/24 • 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.
|
|
Renal and urinary disorders
Acute kidney injury
|
4.3%
1/23 • 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.
|
0.00%
0/24 • 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.
|
|
Renal and urinary disorders
Renal impairment
|
4.3%
1/23 • 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.
|
0.00%
0/24 • 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.
|
Other adverse events
| Measure |
PF-06730512 1000 mg IV
n=23 participants at risk
Participants received PF-06730512 1000 mg IV Q2W.
|
PF-06730512 300 mg IV
n=24 participants at risk
Participants received PF-06730512 300 mg IV Q2W.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.3%
1/23 • 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.
|
8.3%
2/24 • 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.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
2/23 • 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.
|
4.2%
1/24 • 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.
|
|
General disorders
Fatigue
|
13.0%
3/23 • 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.
|
8.3%
2/24 • 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.
|
|
General disorders
Oedema
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
General disorders
Pyrexia
|
8.7%
2/23 • 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.
|
0.00%
0/24 • 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.
|
|
Infections and infestations
COVID-19
|
4.3%
1/23 • 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.
|
8.3%
2/24 • 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.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
Infections and infestations
Viral infection
|
8.7%
2/23 • 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.
|
0.00%
0/24 • 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.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
Investigations
SARS-CoV-2 test positive
|
8.7%
2/23 • 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.
|
8.3%
2/24 • 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.
|
|
Metabolism and nutrition disorders
Dehydration
|
8.7%
2/23 • 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.
|
0.00%
0/24 • 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.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • 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.
|
8.3%
2/24 • 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.
|
|
Nervous system disorders
Headache
|
8.7%
2/23 • 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.
|
12.5%
3/24 • 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.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • 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.
|
0.00%
0/24 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • 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.
|
0.00%
0/24 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER