Clinical trial • Not applicable • Other
Aminohippuric acid for Chronic kidney disease | Kidney failure
Not applicable trial of Aminohippuric acid for Chronic kidney disease | Kidney failure.
Overview
- Trial Therapeutic Area
- Other
- Trial Disease
- Chronic kidney disease | Kidney failure
- Trial Stage
- Not applicable
- Drug Modality
- Small molecule | Radiopharmaceutical
Key dates
- Initial CTIS Submission Date
- 08-03-2024
- First CTIS Authorization Date
- 05-06-2024
Trial design
open-label, sodium iotalamate (125i) — max total dose 3.7 mbq; iotalamate meglumine — max total dose 150 ml-controlled Not applicable trial across 1 site in Netherlands.
- Open Label
- Yes
- Comparator
- SODIUM IOTALAMATE (125I) — max total dose 3.7 MBq; IOTALAMATE MEGLUMINE — max total dose 150 ml
- Real World Control
- Yes
- Target Sample Size
- 200
- Trial Duration For Participant
- 10
Eligibility
Recruits 200 No vulnerable populations selected. Participants are adults (Age ≥ 18 years) and must provide written informed consent. No assent procedures mentioned..
- Pregnancy Exclusion
- Pregnant women and women of child-bearing potential who are not using reliable contraception
- Vulnerable Population
- No vulnerable populations selected. Participants are adults (Age ≥ 18 years) and must provide written informed consent. No assent procedures mentioned.
Inclusion criteria
- {"criterion_text":"- Scheduled to undergo a kidney function measurement test as part of standard care"}
- {"criterion_text":"- Age ≥ 18 years"}
- {"criterion_text":"- Written informed consent"}
Exclusion criteria
- {"criterion_text":"- History of hypersensitivity to iodinated contrast media or one of the excipients in the formulation of iohexol (trometamol, sodium calcium edetate, hydrochloric acid)."}
- {"criterion_text":"- Subjects with (suspected or known) thyrotoxicosis."}
- {"criterion_text":"- Pregnant women and women of child-bearing potential who are not using reliable contraception"}
- {"criterion_text":"- Patients who are unlikely to comply to the trial’s procedure (non-compliance)"}
Endpoints
Primary endpoints
- {"endpoint_text":"- mGFR determined using 125I-Iothalamate and 131I-hippuran","definition_or_measurement_approach":"mGFR determined using 125I-iothalamate and 131I-hippuran (patients receiving 125I-iothalamate and 131I-hippuran during routine clinical care will also receive iohexol); objective is to determine equivalence versus iohexol."}
- {"endpoint_text":"- mGFR determined using iohexol","definition_or_measurement_approach":"mGFR determined using iohexol; used to assess equivalence with mGFR determined using 125I-iothalamate and 131I-hippuran."}
Recruitment
- Planned Sample Size
- 200
- Recruitment Window Months
- 12
- Consent Approach
- Written informed consent required from participants (adults ≥18). Subject information and informed consent form for adults available (L1_SIS and ICF adults). Protocol synopses/documents available in English and Dutch.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 200
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 27-01-2025
- Processing Time Days
- 255
- Number Of Sites
- 1
- Number Of Participants
- 200
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Internal Medicine - Division of Nephrology
- Principal Investigator Name
- Ron Gansevoort
- Principal Investigator Email
- r.t.gansevoort@umcg.nl
- Contact Person Name
- Ron Gansevoort
- Contact Person Email
- r.t.gansevoort@umcg.nl
- Number Of Participants
- 200
Sponsor
Primary sponsor
- Full Name
- Universitair Medisch Centrum Groningen
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Netherlands
Investigational products
- Investigational Product Name
- AMINOHIPPURIC ACID
- Active Substance
- Aminohippuric acid
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS
- Route
- INTRAVENOUS
- Maximum Dose
- 35 g
- Investigational Product Name
- IOTALAMATE MEGLUMINE
- Active Substance
- IOTALAMATE MEGLUMINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- INTRAVENOUS INFUSION
- Maximum Dose
- 150 ml
- Investigational Product Name
- Adrenaline CF 1 mg/ml, oplossing voor injectie
- Active Substance
- EPINEPHRINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Route
- INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
- Authorisation Status
- Authorised (RVG 50812, NL)
- Maximum Dose
- 4 mg
- Investigational Product Name
- OMNIPAQUE 300 mg I/ml
- Active Substance
- IOHEXOL
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS SLOW BOLUS INJECTION
- Route
- INTRAVENOUS SLOW BOLUS INJECTION
- Authorisation Status
- Authorised (RVG 09820, NL)
- Maximum Dose
- 200 ml
- Investigational Product Name
- Tavegyl 1 mg/ml, oplossing voor injectie
- Active Substance
- CLEMASTINE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS USE AND ORAL USE
- Route
- INTRAVENOUS USE AND ORAL USE
- Authorisation Status
- Authorised (RVG 06089, NL)
- Maximum Dose
- 4 mg
- Investigational Product Name
- SODIUM IOTALAMATE (125I)
- Active Substance
- SODIUM IOTALAMATE (125I)
- Modality
- Radiopharmaceutical
- Routes Of Administration
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Route
- INTRAVENOUS BOLUS INJECTION/IV INFUSION
- Maximum Dose
- 3.7 MBq
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