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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01509404
Other study ID # Pro00009601
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2011
Est. completion date December 2015

Study information

Verified date September 2018
Source Medical University of South Carolina
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to assess the incidence and severity of late Cytomegalovirus (CMV) disease, defined as CMV syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with Cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2015
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male and female patients = 18 years of age.

2. Male or female patients who CMV seronegative receiving a kidney, pancreas or liver from a seropositive donor.

3. Female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion.

4. The patient has given written informed consent to participate in the study.

Exclusion Criteria:

1. Solid organ transplant recipient is CMV seropositive at the time of transplant.

2. Recipient or donor is known to be seropositive for human immunodeficiency virus (HIV).

3. Patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives.

4. Patients with thrombocytopenia (<25,000/mm3 ), with an absolute neutrophil count of < 1,000/mm3); and/or leucopoenia (< 2,000/mm3), or anemia (hemoglobin < 6 g/dL) prior to study inclusion.

5. Patient is taking or has been taking an investigational drug in the 30 days prior to transplant.

6. Patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, CMV hyperimmune globulin, basiliximab or corticosteroids.

7. Patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication.

8. Patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human Chorionic Gonadotropin (hCG) laboratory test.

9. Patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator.

10. Inability to cooperate or communicate with the investigator.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Valganciclovir
Valcyte per package insert guidelines for 200 days post transplant
Biological:
CMV hyperimmune globulin
100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant
Drug:
Valganciclovir
valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant

Locations

Country Name City State
United States Medical University of South Carolina Charleston South Carolina

Sponsors (2)

Lead Sponsor Collaborator
Medical University of South Carolina CSL Behring

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Patients With Late CMV Disease Number of any clinically significant late CMV disease, defined as CMV syndrome or tissue-invasive disease occurring after the first 200 days post transplant after 200 days post-transplant until 2 years post-transplant
Secondary Number of Patients With Early CMV Infection 100 days
Secondary Number of Patients With Cell Mediated Immunity Positive CMV quantiferon at last follow-up 2 years
Secondary Renal Function Renal function will be assessed by an estimated creatinine clearance utilizing the abbreviated Modification of Diet in Renal Disease (MDRD) equation at 6, 12, and 24 months after transplant 6, 12, and 24 months after transplant
Secondary Number of Participants With Acute Cellular and/or Antibody Mediated Rejection 2 years
Secondary Number of Participants With Opportunistic Infections 2 years
Secondary Number of Participants With Asymptomatic CMV Viremia 2 years
Secondary Number of Participants With CMV Seroconversions 2 years
See also
  Status Clinical Trial Phase
Terminated NCT02439957 - A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Phase 3
Terminated NCT02439970 - A Phase 3 Study of Brincidofovir Versus Valganciclovir for the Prevention of Cytomegalovirus Disease Phase 3
Active, not recruiting NCT04904614 - Letermovir Use in Heart Transplant Recipients Phase 4
Completed NCT01573039 - Cut Off for the Diagnosis of Cytomegalovirus (CMV) Disease in Serum-positive Kidney Transplant Recipients N/A
Completed NCT04225923 - A Study for Kidney Transplant Recipients at High-Risk of Cytomegalovirus Infection Phase 2
Completed NCT00907686 - TT-CMV Observational Birth Cohort Study N/A
Completed NCT04129398 - MK-8228 (Letermovir) in the Prevention of Human Cytomegalovirus (CMV) Infection and Disease in Adult Japanese Kidney Transplant Recipients (MK-8228-042) Phase 3
Recruiting NCT00828503 - Certican® (Everolimus) Against Cytomegalovirus Disease in Renal Transplant Patients Phase 2