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NCT02837237 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease
A Phase 1 study of Chronic Kidney Disease, sponsored by KBP Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02837237: Completed Phase 1 study of Chronic Kidney Disease, sponsored by KBP Biosciences.
NCT02837237 is a Phase 1 study of Chronic Kidney Disease that has completed, run by KBP Biosciences. The registered enrollment target is 11 participants, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02837237, a Phase 1 study of Chronic Kidney Disease, has completed, sponsored by KBP Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis \[HD\]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female patients with severe CKD (defined as estimated glomerular filtration rate \[eGFR\] ≥15 mL/min/1.73 m2 and ≤29 mL/min/1.73 m2, based on the Modification of Diet in Renal Disease \[MDRD\] equation) and a subset of patients requiring HD.
Primary Outcome
Physical exam, vital signs, EKG, clinical laboratory tests, adverse events
Conditions Studied
Interventions
- DRUG KBP-5074
Study Locations (1)
New Jersey
- KBP Biosciences USA Inc - Princeton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2016-07-13 |
| Est. Completion | 2017-06-30 |
| Phase | Phase 1 |
What the finished NCT02837237 record still lists
NCT02837237 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 11 participants, a relatively small participant target, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Chronic Kidney Disease appearing as the primary indexed condition, and to 1 intervention - of which KBP-5074 is the first listed.
NCT02837237 reports a single indexed study location in New Jersey.
Frequently Asked Questions
What is clinical trial NCT02837237 about?
NCT02837237 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease". This study explores the use of KBP-5074 in patients with advanced stages of Chronic Kidney Disease (CKD) (including patients with severe renal impairment and those on hemodialysis \[HD\]) and to assess the safety, tolerability, and pharmacokinetics (PK) of single doses of KBP-5074 in male and female...
What is the current status of trial NCT02837237?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 11 participants. The study started on 2016-07-13. Estimated completion is 2017-06-30.
What conditions does trial NCT02837237 study?
This clinical trial studies the following conditions: Chronic Kidney Disease.
What interventions are being tested in trial NCT02837237?
The interventions under investigation include: KBP-5074 (DRUG).
Who is sponsoring clinical trial NCT02837237?
This trial is sponsored by KBP Biosciences, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02837237 being conducted?
This trial has 1 study location across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Chronic Kidney Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02837237's enrollment target sits among peer trials
11 100th of 101 higher than 1 of 101 other Chronic Kidney Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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