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NCT04225923 · ClinicalTrials.gov registry record · Phase 2

A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection

A Phase 2 study of Cytomegalovirus Disease, sponsored by Nobelpharma.

Completed
Registry status
Phase 2
Development phase
87
Enrollment target
20
Study locations

NCT04225923: Completed Phase 2 study of Cytomegalovirus Disease, sponsored by Nobelpharma.

NCT04225923 is a Phase 2 study of Cytomegalovirus Disease that has completed, run by Nobelpharma. The registered enrollment target is 87 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04225923, a Phase 2 study of Cytomegalovirus Disease, has completed, sponsored by Nobelpharma.

COMPLETED
Registry status
Phase 2
Development phase
87 participants
Enrollment target
20
Study locations

Study Summary

The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

Primary Outcome

The proportion of patients with CMV disease (CMV syndrome or tissue-invasive CMV disease) or CMV viremia (defined as the detection of 250 IU/mL in plasma measured by PCR analysis in central laboratory or meets the local criteria for CMV viremia measured by PCR analysis or antigenemia testing) per total patients through 16 weeks from first study drug administration. The non-responders include all patients who develop CMV disease or CMV viremia and patients who discontinue from the study in the a

Conditions Studied

Interventions

  • DRUG NPC-21 Low dose
  • DRUG NPC-21 High dose
  • DRUG NPC-21 Placebo

Study Locations (20)

Ohio

  • The Christ Hospital - Cincinnati
  • University of Cincinnati College of Medicine - Cincinnati
  • Cleveland Clinic - Cleveland

Aichi-ken

  • Research site_204 - Nagakute
  • Research site_201 - Nagoya
  • Research site_202 - Toyoake

Georgia

  • Piedmont Healthcare - Atlanta
  • Augusta University Medical Center - Augusta

Texas

  • Renal Disease Research Institute - Dallas
  • University of Texas Southwestern - Dallas

Hyōgo

  • Research site_206 - Kobe
  • Research site_205 - Nishinomiya

Arizona

  • Mayo Clinic - Scottsdale - Phoenix

California

  • California Institute of Renal Research - La Mesa

Michigan

  • University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2020-06-01
Est. Completion 2023-02-08
Phase Phase 2
Nobelpharma

2 total trials

What the finished NCT04225923 record still lists

NCT04225923 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).

The record links to 1 condition, with Cytomegalovirus Disease appearing as the primary indexed condition, and to 3 interventions - of which NPC-21 Low dose is the first listed.

NCT04225923 names 20 study sites across 13 states, led by Ohio, Aichi-ken, Georgia.

Frequently Asked Questions

What is clinical trial NCT04225923 about?

NCT04225923 is a clinical study titled "A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection". The primary objective is to assess the efficacy and safety of NPC-21 when administered prophylactically to cytomegalovirus (CMV) seronegative patients receiving a first kidney transplant from a CMV seropositive donor.

What is the current status of trial NCT04225923?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2020-06-01. Estimated completion is 2023-02-08.

What conditions does trial NCT04225923 study?

This clinical trial studies the following conditions: Cytomegalovirus Disease.

What interventions are being tested in trial NCT04225923?

The interventions under investigation include: NPC-21 Low dose (DRUG), NPC-21 High dose (DRUG), NPC-21 Placebo (DRUG).

Who is sponsoring clinical trial NCT04225923?

This trial is sponsored by Nobelpharma, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04225923 being conducted?

This trial has 20 study locations across Arizona, California, Georgia, Michigan, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT04225923's enrollment target sits among peer trials

87 810th of 2000 higher than 1,189 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04225923, the US trial registry maintained by the National Library of Medicine. NCT04225923 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.