method VALIDation and evaluation of non-radioactive methods to measure Glomerular Filtration Rate

Start 17 Feb 2026 · Status Ongoing, recruiting · 1 EU/EEA countries · 1 sites

Overview

Sponsor-declared trial summary

Phase Therapeutic use (Phase IV)

Status Ongoing, recruiting

Participants planned 200

Countries 1

Sites 1

Chronic Kidney Disease Kidney Failure

To determine the equivalence of mGFR using 125I-iothalamate and 131I-hippuran versus iohexol

Key facts

Sponsor: Universitair Medisch Centrum Groningen
Participant type: Patients
Age range: 18-64 years, 65+ years
Gender: Male and Female
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Trial duration: 17 Feb 2026 → ongoing
Decision date (initial): 2024-06-05
Transition trial: No
Low-intervention: Yes
Rare-disease indication: No
Vulnerable population: No

External identifiers

EU CT number: 2023-509156-34-02
ClinicalTrials.gov: NCT06259422

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Diagnosis

To determine the equivalence of mGFR using 125I-iothalamate and 131I-hippuran versus iohexol

Secondary objectives 1

To determine the inter-day variability (within-subject variation) of the kidney function measurements.

Conditions and MedDRA coding

Chronic Kidney Disease Kidney Failure

Study design 2 periods

#	Title	Allocation	Blinding	Roles blinded	Arms
1	Routine clinical care visit (Part A) Patients receiving 125I-iothalamate and 131I-hippuran during routine clinical care, will also receive iohexol.	Not Applicable	None
2	Second study visit (Part B) For Part B of the study, 20 subjects who consented to this part of the study will return to the clinic after 10 days, in order to undergo a second 125I-iothalamate and 131I-hippuran, and iohexol kidney function measurement.	Not Applicable	None

Regulatory references

Plan to share IPD: No

EU CT number	Title	Sponsor
2023-509156-34-00	VALIDGFR; method VALIDation and evaluation of non-radioactive methods to measure Glomerular Filtration Rate	Universitair Medisch Centrum Groningen

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

Scheduled to undergo a kidney function measurement test as part of standard care
Age ≥ 18 years
Written informed consent

Exclusion criteria 4

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)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

mGFR determined using 125I-Iothalamate and 131I-hippuran
mGFR determined using iohexol

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

OMNIPAQUE 300 mg I/ml

PRD381491 · Product

Active substance: Iohexol
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS SLOW BOLUS INJECTION
Max daily dose: 200 ml millilitre(s)
Max total dose: 200 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V08AB02 — IOHEXOL
Marketing authorisation: RVG 09820
MA holder: GE HEALTHCARE B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Comparator 2

Sodium Iotalamate (125I)

SUB10565MIG · Substance

Active substance: Sodium Iotalamate (125I)
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS BOLUS INJECTION/IV INFUSION
Max daily dose: 3.7 MBq megabecquerel(s)
Max total dose: 3.7 MBq megabecquerel(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Iotalamate Meglumine

SUB02753MIG · Substance

Active substance: Iotalamate Meglumine
Pharmaceutical form: INJECTION
Route of administration: INTRAVENOUS INFUSION
Max daily dose: 150 ml millilitre(s)
Max total dose: 150 ml millilitre(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: - — -
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Auxiliary 3

—

SCP2100749 · ATC

Route of administration: INTRAVENOUS
Max daily dose: 35 g gram(s)
Max total dose: 35 g gram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: V04CH30 — AMINOHIPPURIC ACID
Marketing authorisation: -
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Tavegyl 1 mg/ml, oplossing voor injectie

PRD8065824 · Product

Active substance: Clemastine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS USE AND ORAL USE
Max daily dose: 2 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: R06AA04 — CLEMASTINE
Marketing authorisation: RVG 06089
MA holder: GEBRO PHARMA GMBH
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Adrenaline CF 1 mg/ml, oplossing voor injectie

PRD502619 · Product

Active substance: Epinephrine
Pharmaceutical form: SOLUTION FOR INJECTION
Route of administration: INTRAVENOUS/SUBCUTANEOUS/INTRAMUSCULAR
Max daily dose: 4 mg milligram(s)
Max total dose: 4 mg milligram(s)
Max treatment duration: 1 Day(s)
Authorisation status: Authorised
ATC code: C01CA — ADRENERGIC AND DOPAMINERGIC AGENTS
Marketing authorisation: RVG 50812
MA holder: CENTRAFARM B.V.
MA country: Netherlands
Paediatric formulation: No
Orphan designation: No
Modified vs. Marketing Authorisation: No

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation: Universitair Medisch Centrum Groningen
Address: Hanzeplein 1
City: Groningen
Postcode: 9713 GZ
Country: Netherlands

Scientific contact point

Organisation: Universitair Medisch Centrum Groningen
Contact name: Ron T Gansevoort

Public contact point

Organisation: Universitair Medisch Centrum Groningen
Contact name: Abdulfataah Mohamed

Locations

1 EU/EEA country · 1 investigational sites

By country

Country	MS status	Planned subjects	Sites
Netherlands	Ongoing, recruiting	200	1
Rest of world	—	0	—

Investigational sites

Netherlands

1 site · Ongoing, recruiting

Universitair Medisch Centrum Groningen

Internal Medicine - Division of Nephrology, Hanzeplein 1, 9713 GZ, Groningen

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Country	Trial start	Trial end	Recruitment start	Recruitment end	Early termination
Netherlands	2025-02-24		2025-02-24

Oversight and notifications

Regulatory notifications under CTR Articles 38, 52, 53, 54 and 77

Temporary halts 1 · Art. 38 CTR

Temporary halt TH-118115

Halt date: 2025-09-28
Planned restart: 2026-02-17
Member states concerned: Netherlands
Publication date: 2026-02-05
Reason: Medicinal Product related
Explanation: The addition of an AxMP to determine the effective renal plasma flow (ERPF) to replace the previous product that was used to determine the ERPF.
Benefit-risk balance changed: No
Treatment stopped: No

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 9 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Type	Title	Version
Protocol (for publication)	D1_2023-509156-34_redacted	4
Recruitment arrangements (for publication)	K1_Recruitment arrangements	1
Subject information and informed consent form (for publication)	L1_SIS and ICF adults_redacted	1
Subject information and informed consent form (for publication)	L1_SIS and ICF adults-tracked changes	3
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Conray_EN	2
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Glofil-125 EN	1
Summary of Product Characteristics (SmPC) (for publication)	E2_SmPC Omnipaque 300 NL	1
Synopsis of the protocol (for publication)	D1_Protocol synopsis NL_CLEAN	3
Synopsis of the protocol (for publication)	D1_Protocol synopsis_EN_CLEAN	2

Application history

3 submissions — initial application plus substantial / non-substantial modifications

#	Type	Code	Submitted	Reference MS	Conclusion	Decision date
1	INITIAL	IN	2024-03-08	Netherlands	Acceptable 2024-05-31	2024-06-05
2	SUBSTANTIAL MODIFICATION	SM-1	2024-10-09	Netherlands	Acceptable 2025-01-21	2025-01-27
3	SUBSTANTIAL MODIFICATION	SM-4	2025-09-29	Netherlands	Acceptable with conditions 2025-12-22	2025-12-31

method VALIDation and evaluation of non-radioactive methods to measure Glomerular Filtration Rate

Overview

Key facts

External identifiers

Trial design

Main objective

Secondary objectives 1

Conditions and MedDRA coding

Study design 2 periods

Regulatory references

Eligibility criteria

Inclusion criteria 3

Exclusion criteria 4

Endpoints

Primary endpoints 2

Investigational products

Test 1

Comparator 2

Auxiliary 3

Sponsors and contacts

Universitair Medisch Centrum Groningen

Scientific contact point

Public contact point

Locations

By country

Investigational sites

Country notifications

Oversight and notifications

Temporary halts 1 · Art. 38 CTR

Results and documents

Documents 9 files

Application history

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