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COMPLETED Phase 1

A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis

NCT03393013 · View on ClinicalTrials.gov ↗

Study Summary

This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).

Interventions

  • DRUG KZR-616

Study Locations (20)

Florida

  • SouthCoast Research Center, Inc. — Miami
  • Hope Clinical Trials, Inc. — Miami
  • Omega Research Maitland — Orlando
  • Arthritis Center, Inc — Palm Harbor
  • Advent Health Medical Group — Tampa

New York

  • Northwell Health — Great Neck
  • NYU Langone Orthopedic Center - Seligman Center for Advanced Therapeutics — New York
  • University of Rochester Medical Center — Rochester

Texas

  • MedResearch, Inc. — El Paso
  • Accurate Clinical Research, Inc. — Houston
  • Accurate Clinical Management, LLC — Houston

California

  • Academic Medical Research Institute — Los Angeles
  • Inland Rheumatology Clinical Trials, Inc. — Upland

Victoria

  • Monash Health — Clayton
  • The Royal Melbourne Hospital — Parkville

Iowa

  • University of Iowa — Iowa City

Ohio

  • The Ohio State University Wexner Medical Center — Columbus

South Carolina

  • SC Nephrology & Hypertension Center, Inc. — Orangeburg

Trial Details

FieldValue
Enrollment Target 69 participants
Start Date 2018-02-20
Est. Completion 2022-08-04
Phase Phase 1

Sponsor

Kezar Life Sciences

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03393013

The ClinicalTrials.gov registry entry for NCT03393013 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 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kezar Life Sciences, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention — of which KZR-616 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: NCT03393013 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, New York, Texas. 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 NCT03393013 about?

NCT03393013 is a clinical study titled "A Study of KZR-616 in Patients With SLE With and Without Lupus Nephritis". This was a Phase 1b/2, multi-center study in which patients received KZR-616, administered as a subcutaneous (SC) injection weekly for 13 weeks (Phase 1b) or 24 weeks (Phase 2).

What is the current status of trial NCT03393013?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 69 participants. The study started on 2018-02-20. Estimated completion is 2022-08-04.

What conditions does trial NCT03393013 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus Nephritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03393013?

The interventions under investigation include: KZR-616 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03393013?

This trial is sponsored by Kezar Life Sciences, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03393013 being conducted?

This trial has 20 study locations across California, Florida, Iowa, New York, Ohio. 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