Trial Outcomes & Findings for Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease (NCT NCT02837237)
NCT ID: NCT02837237
Last Updated: 2025-12-30
Results Overview
Physical exam, vital signs, EKG, clinical laboratory tests, adverse events
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
11 participants
Primary outcome timeframe
312 hours
Results posted on
2025-12-30
Participant Flow
Participant milestones
| Measure |
KBP-5074
Single oral dose
KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
Baseline characteristics by cohort
| Measure |
KBP-5074
n=11 Participants
Single oral dose
KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=174 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
8 Participants
n=174 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=174 Participants
|
|
Age, Continuous
|
53.5 years
n=174 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=174 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=174 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=174 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=174 Participants
|
|
systolic blood pressure
|
124.8 mmHg
STANDARD_DEVIATION 14.18 • n=174 Participants
|
PRIMARY outcome
Timeframe: 312 hoursPhysical exam, vital signs, EKG, clinical laboratory tests, adverse events
Outcome measures
| Measure |
KBP-5074
n=11 Participants
Single oral dose
KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.
|
|---|---|
|
Number of Participants With Treatment-related Adverse Events
|
0 Participants
|
Adverse Events
KBP-5074
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
KBP-5074
n=11 participants at risk
Single oral dose
KBP-5074: In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session.
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|---|---|
|
General disorders
fatigue
|
9.1%
1/11 • Number of events 1 • 14 days
An overall summary of the number and percentage of subjects in each category were presented, as well as an overall summary of the number of events in each category. The number and percentage of subjects reporting AEs in each category above were summarized by study part and cohort according to the system organ class (SOC) and preferred term (PT) assigned to the event using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
|
|
Injury, poisoning and procedural complications
procedural hypotension
|
9.1%
1/11 • Number of events 1 • 14 days
An overall summary of the number and percentage of subjects in each category were presented, as well as an overall summary of the number of events in each category. The number and percentage of subjects reporting AEs in each category above were summarized by study part and cohort according to the system organ class (SOC) and preferred term (PT) assigned to the event using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
|
|
Investigations
increased creatinine
|
9.1%
1/11 • Number of events 1 • 14 days
An overall summary of the number and percentage of subjects in each category were presented, as well as an overall summary of the number of events in each category. The number and percentage of subjects reporting AEs in each category above were summarized by study part and cohort according to the system organ class (SOC) and preferred term (PT) assigned to the event using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
|
|
Metabolism and nutrition disorders
hyperkalemia
|
9.1%
1/11 • Number of events 1 • 14 days
An overall summary of the number and percentage of subjects in each category were presented, as well as an overall summary of the number of events in each category. The number and percentage of subjects reporting AEs in each category above were summarized by study part and cohort according to the system organ class (SOC) and preferred term (PT) assigned to the event using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
9.1%
1/11 • Number of events 1 • 14 days
An overall summary of the number and percentage of subjects in each category were presented, as well as an overall summary of the number of events in each category. The number and percentage of subjects reporting AEs in each category above were summarized by study part and cohort according to the system organ class (SOC) and preferred term (PT) assigned to the event using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
|
|
Nervous system disorders
headache
|
9.1%
1/11 • Number of events 1 • 14 days
An overall summary of the number and percentage of subjects in each category were presented, as well as an overall summary of the number of events in each category. The number and percentage of subjects reporting AEs in each category above were summarized by study part and cohort according to the system organ class (SOC) and preferred term (PT) assigned to the event using the Medical Dictionary for Regulatory Activities (MedDRA) version 19.0.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place