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COMPLETED Phase 1

Safety, Tolerability, and Pharmacokinetics of KBP-5074 Following Oral Administration in Chronic Kidney Disease

NCT02837237 · View on ClinicalTrials.gov ↗

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

3 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02837237

The ClinicalTrials.gov registry entry for NCT02837237 describes a study currently listed as completed. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is KBP Biosciences, which has 3 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02837237 reports 1 study location spanning 1 distinct geographic area — top geographies include New Jersey. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02837237?

The interventions under investigation include: KBP-5074 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02837237?

This trial is sponsored by KBP Biosciences, which has 3 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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