Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03488771
Other study ID # CHMerkurQFM
Secondary ID
Status Recruiting
Phase
First received March 22, 2018
Last updated April 4, 2018
Start date March 5, 2017
Est. completion date December 1, 2018

Study information

Verified date April 2018
Source Clinical Hospital Merkur
Contact Ivan Margeta, MD
Phone +385921384970
Email ivan.margeta@kb-merkur.hr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

All kidney transplant recipients require immunosuppression, the net level of which is difficult to assess. Current practice in assessing immune reactivity is to monitor levels of some immunosuppressive drugs. QuantiFERON Monitor® (QFM) is an in vitro diagnostic test that detects interferon-γ (IFN-γ) release in peripheral blood. Its clinical utility in assessment of the net state of immunosuppression in kidney transplant recipients has not been well studied. The aim of our study is to evaluate the discriminating value of QFM testing results for infection and rejection in a single-centre cohort of kidney transplant recipients.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date December 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Kidney/Liver kidney/Simultaneous pancreas and kidney transplantation

Exclusion Criteria:

Study Design


Locations

Country Name City State
Croatia Clinical Hospital Merkur Zagreb HR

Sponsors (2)

Lead Sponsor Collaborator
Clinical Hospital Merkur Clinical Hospital Centre Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type Measure Description Time frame Safety issue
Primary Infection Interferon gamma level in patients with infection throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
Secondary Rejection Interferon gamma levels in patients with rejection throughout the study period (Kidney transplant recipients from 1 day date of tx to 15 years after tx)
See also
  Status Clinical Trial Phase
Recruiting NCT04491552 - TruGraf® Long-term Clinical Outcomes Study
Withdrawn NCT04560582 - Immunosuppression Reduction in Failed Allograft Guided by cfDNA
Completed NCT05747274 - SRDK0921_ Analytical Performance Study
Not yet recruiting NCT05482100 - CLinical Utility of the omnigrAf® biomarkeR Panel In The Care of kidneY Transplant Recipients
Recruiting NCT06243289 - Improving KIdney Transplantation With Cellular Therapy Study
Not yet recruiting NCT06025240 - Expanding the Scope of Post-transplant HLA-specific Antibody Detection and Monitoring in Renal Transplant Recipients
Completed NCT04367610 - Effects of A Standardized Treatment Approach on Kidney Transplant Recipients With Antibody-Mediated Rejection
Enrolling by invitation NCT06126380 - Long-Term Safety and Efficacy of Tegoprubart in Kidney Transplant Recipients Phase 2
Terminated NCT05747053 - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Active, not recruiting NCT03714113 - Donor-specific Anti-HLA Antibodies Monitoring in Kidney Transplant Recipients N/A
Recruiting NCT04091984 - The PROspera Kidney Transplant ACTIVE Rejection Assessment Registry (ProActive)
Recruiting NCT05335538 - TruGraf and TRAC In Pediatrics Study
Completed NCT03663335 - Study of Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in Kidney Transplant Recipients Phase 2
Completed NCT03652402 - Precision Risk Stratification in Kidney Transplant Patients - EU-TRAIN
Recruiting NCT04773392 - Simplified IMmunosuppressive Protocol Utilizing Low Dose EnvarsusXR Phase 4
Terminated NCT02974686 - Conversion From MPA to Zortress (Everolimus) for GI Toxicity Post-renal Transplantation Phase 4
Completed NCT03873623 - The TOGETHER Project - Kidney
Terminated NCT04156204 - Immunosuppressant Medication Dosed Daily After Kidney Transplant Early Phase 1
Completed NCT04601155 - Transition of Renal Patients Using AlloSure Into Community Kidney Care
Completed NCT03874299 - The TOGETHER Project - Kidney RNA-seq Validation