Chronic Kidney Diseases Clinical Trial
— VALIDGFROfficial title:
Method VALIDation and Evaluation of Non-radioactive Methods to Measure Glomerular Filtration Rate
This study is a single centre intervention study to compare two methods of determining the measured glomerular filtration rate (mGFR). Subjects who receive radioactively labeled iothalamate (125I) and hippuran (131I) within the framework of routine clinical care, will be co-administered iohexol. The primary trial endpoint is the mGFR when administered 125I-iothalamate and 131I-hippuran versus iohexol. By determining the mGFR using both iohexol and iothalamate in the same patients, a direct comparison of the two methods can be made in terms of their accuracy and precision. This makes it possible to determine the potential use of the non-radioactive measurement method as an alternative to the radioactive method and thus lower the overall radioactive burden for patients and personnel.
Status | Not yet recruiting |
Enrollment | 208 |
Est. completion date | September 1, 2025 |
Est. primary completion date | September 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Scheduled to undergo a kidney function measurement test as part of standard care. - 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). |
Country | Name | City | State |
---|---|---|---|
Netherlands | University Medical Centre Groningen | Groningen |
Lead Sponsor | Collaborator |
---|---|
University Medical Center Groningen |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Subgroup analysis mGFR | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on important patient characteristics. This will be assessed per subgroup depending on the glomerular filtration rate (GFR) of the patients (patients with a mGFR: <30, 30-90, >90) | Through study completion, an average of 1 year | |
Other | Subgroup analysis sex | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the sex of the patient. | Through study completion, an average of 1 year | |
Other | Subgroup analysis age | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the age of the patient. | Through study completion, an average of 1 year | |
Other | Subgroup analysis BMI | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the BMI of the patient. | Through study completion, an average of 1 year | |
Other | Subgroup analysis creatinine | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the creatinine levels of the patient. | Through study completion, an average of 1 year | |
Other | Subgroup analysis cystatin C | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the cystatin C levels of the patient. | Through study completion, an average of 1 year | |
Other | Subgroup analysis BSA | A subgroup analysis will be performed to assess whether precision and accuracy of the mGFR are dependent on the Body Surface Area (BSA) of the patient. | Through study completion, an average of 1 year | |
Primary | mGFR Iohexol | mGFR that is determined using the iohexol method | Through study completion, an average of 1 year | |
Primary | mGFR Iothalamate and hippuran | mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method | Through study completion, an average of 1 year | |
Secondary | Repeated mGFR using iohexol on a separate study day | mGFR that is determined using the iohexol method | Through study completion, an average of 1 year | |
Secondary | Repeated mGFR using iothalamate and hippuran on a separate study day | mGFR that is determined using the warm 125I-iothalamate and 131I-hippuran method | Through study completion, an average of 1 year |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06386172 -
Electronic Decision-support System to Improve Detection and Care of Patients With Chronic Kidney Disease in Stockholm
|
N/A | |
Recruiting |
NCT04910867 -
APOL1 Genetic Testing Program for Living Donors
|
N/A | |
Completed |
NCT03434145 -
Changes of Ocular Structures After Hemodialysis in Patients With Chronic Kidney Diseases
|
N/A | |
Recruiting |
NCT04984226 -
Sodium Bicarbonate and Mitochondrial Energetics in Persons With CKD
|
Phase 2 | |
Active, not recruiting |
NCT05887817 -
Effects of Finerenone on Vascular Stiffness and Cardiorenal Biomarkers in T2D and CKD (FIVE-STAR)
|
Phase 4 | |
Recruiting |
NCT05318196 -
Molecular Prediction of Development, Progression or Complications of Kidney, Immune or Transplantation-related Diseases
|
||
Terminated |
NCT05022329 -
COVID-19 Vaccine Boosters in Patients With CKD
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT04925661 -
HEC53856 Phase Ib Study in Patients With Non-dialysis Renal Anemia
|
Phase 1 | |
Recruiting |
NCT04961164 -
Resistant Starch Prebiotic Effects in Chronic Kidney Disease
|
N/A | |
Completed |
NCT05015647 -
Low Protein Diet in CKD Patients at Risk of Malnutrition
|
N/A | |
Completed |
NCT03426787 -
Helping Empower Liver and Kidney Patients
|
N/A | |
Recruiting |
NCT06094231 -
Treating Patients With Renal Impairment and Altered Glucose MetAbolism With TherapeutIc Carbohydrate Restriction and Sglt2-Inhibiton - a Pilot Study
|
N/A | |
Completed |
NCT04363554 -
The Kidneys Ability to Concentrate and Dilute Urine in Patients With Autosomal Dominant Polycystic Kidney Disease
|
N/A | |
Recruiting |
NCT04831021 -
Pre- or Per-dialytic Physical Exercise : a Cardioprotective Role?
|
N/A | |
Terminated |
NCT04877847 -
Multi-Center Trial Utilizing Low Frequency Ultrasound in the Prevention of Post-Contrast Acute Kidney Injury
|
N/A | |
Recruiting |
NCT04422652 -
Combination of Novel Therapies for CKD Comorbid Depression
|
Phase 2 | |
Completed |
NCT05055362 -
Effect a Honey, Spice-blended Baked Good Has on Salivary Inflammation Markers in Adults: a Pilot Study
|
N/A | |
Not yet recruiting |
NCT06330480 -
Check@Home: General Population Screening for Early Detection of Atrial Fibrillation and Chronic Kidney Disease
|
N/A | |
Recruiting |
NCT03176862 -
Left Ventricular Fibrosis in Chronic Kidney Disease
|
N/A | |
Terminated |
NCT02539680 -
Intestinal Phosphate Transporter Expression in CKD Patients
|
N/A |