Trial Outcomes & Findings for Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney Disease (NCT NCT03574363)
NCT ID: NCT03574363
Last Updated: 2025-12-30
Results Overview
Change in trough cuff resting seated SBP from baseline to Day 84.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
162 participants
Primary outcome timeframe
Baseline to Day 84
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
KBP-5074 .25mg
KBP-5074 low dose
|
KBP-5074 .5mg
KBP-5074 high dose
|
Placebo
Placebo to match active drug
|
|---|---|---|---|
|
Overall Study
STARTED
|
51
|
54
|
57
|
|
Overall Study
COMPLETED
|
47
|
44
|
47
|
|
Overall Study
NOT COMPLETED
|
4
|
10
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2b Study of KBP-5074 in Subjects With Uncontrolled Hypertension and Advanced Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
KBP-5074 .25mg
n=51 Participants
KBP-5074 low dose
|
KBP-5074 .5mg
n=54 Participants
KBP-5074 high dose
|
Placebo
n=57 Participants
Placebo to match active drug
|
Total
n=162 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=174 Participants
|
24 Participants
n=166 Participants
|
27 Participants
n=167 Participants
|
74 Participants
n=164 Participants
|
|
Age, Categorical
>=65 years
|
28 Participants
n=174 Participants
|
30 Participants
n=166 Participants
|
30 Participants
n=167 Participants
|
88 Participants
n=164 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=174 Participants
|
23 Participants
n=166 Participants
|
23 Participants
n=167 Participants
|
73 Participants
n=164 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=174 Participants
|
31 Participants
n=166 Participants
|
34 Participants
n=167 Participants
|
89 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
12 Participants
n=174 Participants
|
8 Participants
n=166 Participants
|
15 Participants
n=167 Participants
|
35 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
39 Participants
n=174 Participants
|
46 Participants
n=166 Participants
|
42 Participants
n=167 Participants
|
127 Participants
n=164 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=174 Participants
|
5 Participants
n=166 Participants
|
2 Participants
n=167 Participants
|
12 Participants
n=164 Participants
|
|
Race (NIH/OMB)
White
|
46 Participants
n=174 Participants
|
49 Participants
n=166 Participants
|
54 Participants
n=167 Participants
|
149 Participants
n=164 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
0 Participants
n=167 Participants
|
0 Participants
n=164 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
0 Participants
n=166 Participants
|
1 Participants
n=167 Participants
|
1 Participants
n=164 Participants
|
|
Region of Enrollment
North America
|
18 participants
n=174 Participants
|
18 participants
n=166 Participants
|
20 participants
n=167 Participants
|
56 participants
n=164 Participants
|
|
Region of Enrollment
Europe
|
31 participants
n=174 Participants
|
34 participants
n=166 Participants
|
36 participants
n=167 Participants
|
101 participants
n=164 Participants
|
|
Region of Enrollment
Chile
|
1 participants
n=174 Participants
|
2 participants
n=166 Participants
|
0 participants
n=167 Participants
|
3 participants
n=164 Participants
|
|
Region of Enrollment
Israel
|
1 participants
n=174 Participants
|
0 participants
n=166 Participants
|
1 participants
n=167 Participants
|
2 participants
n=164 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 84Change in trough cuff resting seated SBP from baseline to Day 84.
Outcome measures
| Measure |
Placebo Tablet
n=57 Participants
Placebo tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.25 mg Tablet
n=51 Participants
KBP-5074 0.25 mg tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.5 mg Tablet
n=54 Participants
KBP-5074 0.5 mg tablet QD orally, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
|---|---|---|---|
|
Systolic Blood Pressure
Day 84
|
150.4 mmHg
Standard Error 1.98
|
142.8 mmHg
Standard Error 2.65
|
139.9 mmHg
Standard Error 2.65
|
|
Systolic Blood Pressure
Change from Baseline to Day 84
|
-5.3 mmHg
Standard Error 2.39
|
-11.5 mmHg
Standard Error 2.9
|
-15.9 mmHg
Standard Error 3.15
|
|
Systolic Blood Pressure
Baseline
|
155.8 mmHg
Standard Error 1.44
|
154.3 mmHg
Standard Error 2.11
|
155.7 mmHg
Standard Error 2.01
|
SECONDARY outcome
Timeframe: Baseline to Day 84Change in trough cuff seated DBP from baseline to Day 84
Outcome measures
| Measure |
Placebo Tablet
n=57 Participants
Placebo tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.25 mg Tablet
n=51 Participants
KBP-5074 0.25 mg tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.5 mg Tablet
n=54 Participants
KBP-5074 0.5 mg tablet QD orally, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
|---|---|---|---|
|
Diastolic Blood Pressure
Change from Baseline to Day 84
|
-2.0 mmHg
Standard Error 1.41
|
-6.7 mmHg
Standard Error 2.02
|
-7.0 mmHg
Standard Error 2.23
|
|
Diastolic Blood Pressure
Baseline
|
85.9 mmHg
Standard Error 1.52
|
89 mmHg
Standard Error 1.7
|
88.4 mmHg
Standard Error 1.78
|
|
Diastolic Blood Pressure
Day 84
|
83.8 mmHg
Standard Error 1.34
|
82.2 mmHg
Standard Error 1.68
|
81.4 mmHg
Standard Error 1.90
|
SECONDARY outcome
Timeframe: Baseline to Day 84Change in UACR from baseline to Day 84
Outcome measures
| Measure |
Placebo Tablet
n=43 Participants
Placebo tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.25 mg Tablet
n=36 Participants
KBP-5074 0.25 mg tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.5 mg Tablet
n=44 Participants
KBP-5074 0.5 mg tablet QD orally, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
|---|---|---|---|
|
UACR
Baseline
|
483.7038 mg/g
Interval 288.6661 to 810.5189
|
700.4447 mg/g
Interval 465.8093 to 1053.2694
|
519.0621 mg/g
Interval 328.9336 to 819.0876
|
|
UACR
Day 84
|
313.91930 mg/g
Interval 160.8878 to 612.5096
|
435.7897 mg/g
Interval 256.8354 to 739.4333
|
372.0062 mg/g
Interval 217.4223 to 636.4968
|
|
UACR
Change from Baseline to Day 84
|
0.6927 mg/g
Interval 0.4868 to 0.9858
|
0.6222 mg/g
Interval 0.359 to 1.0781
|
0.7328 mg/g
Interval 0.4774 to 1.1249
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Day 84Total KBP-5074 concentration
Outcome measures
Outcome data not reported
Adverse Events
Placebo Tablet
Serious events: 4 serious events
Other events: 15 other events
Deaths: 2 deaths
KBP-5074 0.25 mg Tablet
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
KBP-5074 0.5 mg Tablet
Serious events: 2 serious events
Other events: 34 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Tablet
n=57 participants at risk
Placebo tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.25 mg Tablet
n=51 participants at risk
KBP-5074 0.25 mg tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.5 mg Tablet
n=54 participants at risk
KBP-5074 0.5 mg tablet QD orally, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
|---|---|---|---|
|
Infections and infestations
pneumonia
|
1.8%
1/57 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/54 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
General disorders
Death
|
1.8%
1/57 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/54 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.00%
0/57 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
1.9%
1/54 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/57 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
2.0%
1/51 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/54 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Cardiac disorders
Myocardial infarction
|
1.8%
1/57 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
1.9%
1/54 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Gastrointestinal disorders
Gastric ulcer hemorrhage
|
1.8%
1/57 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/54 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
Other adverse events
| Measure |
Placebo Tablet
n=57 participants at risk
Placebo tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.25 mg Tablet
n=51 participants at risk
KBP-5074 0.25 mg tablet QD orally, 84 days
KBP-5074 0.25 mg tablet: Oral administration, QD, 84 days
|
KBP-5074 0.5 mg Tablet
n=54 participants at risk
KBP-5074 0.5 mg tablet QD orally, 84 days
KBP-5074 0.5 mg tablet: Oral administration, QD, 84 days
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.00%
0/57 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
3.7%
2/54 • Number of events 2 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
24.6%
14/57 • Number of events 26 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
29.4%
15/51 • Number of events 33 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
51.9%
28/54 • Number of events 52 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Renal and urinary disorders
CKD
|
1.8%
1/57 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
3.9%
2/51 • Number of events 2 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
5.6%
3/54 • Number of events 3 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Renal and urinary disorders
renal failure
|
0.00%
0/57 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/51 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
1.9%
1/54 • Number of events 1 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
|
Investigations
eGFR decrease
|
0.00%
0/57 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
5.9%
3/51 • Number of events 3 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
0.00%
0/54 • AE collection started with the signing of the ICF followed by 4 weeks of screening period, then 2 weeks of run-in period, then 84 days of double-blind study treatment, then 4 weeks of safety follow up. Total AE collection period was 22 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Results are only unblinded after full study is completed. Therefore, PI would be unable to disclose results until after the full database lock and unblinding.
- Publication restrictions are in place
Restriction type: OTHER