method VALIDation and evaluation of non-radioactive methods tomeasure Glomerular Filtration Rate
Phase 1
- Conditions
- Chronic Kidney DiseaseKidney FailureTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
- Registration Number
- CTIS2023-509156-34-02
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 208
Inclusion Criteria
Scheduled to undergo a kidney function measurement test as part of standard care, Age = 18 years, Written informed consent
Exclusion Criteria
History of hypersensitivity to iodinated contrast media or one of the excipients in the formulation of iohexol (trometamol, sodium calcium edetate, hydrochloric acid)., Subjects with (suspected or known) thyrotoxicosis., Pregnant women and women of child-bearing potential who are not using reliable contraception, Patients who are unlikely to comply to the trial’s procedure (non-compliance)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To determine the equivalence of mGFR using 125I-iothalamate and 131I-hippuran versus iohexol;Secondary Objective: To determine the inter-day variability (within-subject variation) of the kidney function measurements.;Primary end point(s): mGFR determined using 125I-Iothalamate and 131I-hippuran, mGFR determined using iohexol
- Secondary Outcome Measures
Name Time Method