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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 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.

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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.

Conditions Studied

Interventions

  • DRUG KBP-5074

Study Locations (1)

New Jersey

  • KBP Biosciences USA Inc - Princeton

Trial Details

FieldValue
Enrollment Target 11 participants
Start Date 2016-07-13
Est. Completion 2017-06-30
Phase Phase 1

Sponsor

KBP Biosciences

12 total trials

What the Registry Record Tells You About NCT02837237

The ClinicalTrials.gov registry entry for NCT02837237 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 3,207-participant average among 101 other Chronic Kidney Disease trials with a reported enrollment target (100% lower). The listed sponsor is KBP Biosciences, which has 12 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.