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Strategic Help With Immunoglobulin to Enhance Protect Against Late Disease (CMV)

NCT06958796 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-22

No results posted yet for this study

Summary

This study is being done to find out if administering CytoGam® after the end of standardly prescribed preventive antiviral treatment can help transplant recipients with a high risk for developing late CMV disease after a liver and/or kidney transplant.

Conditions

  • Cytomegalovirus
  • Organ Transplant
  • Kidney Transplant; Complications
  • Liver Transplant Complications
  • Simultaneous Liver-Kidney Transplantation; Complications

Interventions

DRUG

Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months

The interventional arm will receive Cytomegalovirus Immune Globulin Intravenous (Human) monthly for three months as (150 mg/kg) for 3 consecutive months (Days 0, 28 and 56 +/- 3 days). The non-interventional arm will not receive any intervention.

Sponsors & Collaborators

  • University of Texas Southwestern Medical Center

    collaborator OTHER

  • Kamada, Ltd.

    collaborator INDUSTRY

  • Camille N. Kotton, MD

    lead OTHER

Principal Investigators

  • Camille Kotton, MD, FIDSA, FAST · Massachusetts General Hospital

  • David Wojciechowski, DO · University of Texas Southwestern Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-27
Primary Completion
2027-12-30
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06958796 on ClinicalTrials.gov