Clinical trial • Phase IV • Other

pyruvic acid for Autosomal dominant polycystic kidney disease (ADPKD) | Chronic kidney disease

Phase IV trial of pyruvic acid for Autosomal dominant polycystic kidney disease (ADPKD) | Chronic kidney disease.

Overview

Trial Therapeutic Area: Other
Trial Disease: Autosomal dominant polycystic kidney disease (ADPKD) | Chronic kidney disease
Trial Stage: Phase IV
Drug Modality: Radiopharmaceutical

open-label, none/not specified-controlled Phase IV trial across 1 site in Denmark.

Recruits 30 No vulnerable population selected; participants are adults (aged 18–85); informed consent obtained from participants..

Pregnancy Exclusion: Pre-menopausal women must be confirmed non-pregnant by an onsite test. (All female participants)
Vulnerable Population: No vulnerable population selected; participants are adults (aged 18–85); informed consent obtained from participants.

{"criterion_text":"- Aged 18 – 85 years (all participants)"}
{"criterion_text":"- Pre-menopausal women must be confirmed non-pregnant by an onsite test. (All female participants)"}
{"criterion_text":"- Autosomal dominant polycystic kidney disease. (PKD group)"}
{"criterion_text":"- CKD for any reason except PKD. (CKD group)"}
{"criterion_text":"- Recent biopsy (within 3 months of MRI). (CKD group)"}
{"criterion_text":"- eGFR > 60 (PKD patients)"}

{"criterion_text":"- Contraindications for MRI with contrast: - eGFR less than 30 ml/min/1.73m2 - Significant cardiac disease such as severe left ventricular outflow obstruction - Significant obstructive lung disease or severe asthma - Pacemaker, neurostimulator or cholera implant - Metal foreign bodies such as fragments and irremovable piercings - Unsafe medical implants (safety of heart valves, hips and the like must be confirmed) - Claustrophobia - Largest circumference including arms > 160 cm"}
{"criterion_text":"- Competing renal or systemic disease (except unspecific renal MRI findings, hypertension, atherosclerosis, well-regulated diabetes and hyperlipidemia/cholesterolemia which are allowed)"}
{"criterion_text":"- Renovascular disease"}
{"criterion_text":"- Allergy to pyruvate"}

{"endpoint_text":"- MRI signature of the kidney","definition_or_measurement_approach":"As assessed by multi-parametric MRI including hyperpolarized [1-13C]pyruvate (as described in main objective)"}

{"endpoint_text":"- Measures of kidney function in blood and urine.","definition_or_measurement_approach":"Clinical measures of kidney function assessed in blood and urine (as stated)"}
{"endpoint_text":"- Expired CO2 measures","definition_or_measurement_approach":"Expired CO2 measurements (as stated)"}

Planned Sample Size: 30
Recruitment Window Months: 84
Consent Approach: Informed consent obtained from participants; subject information and informed consent forms available (documents titled 'Deltagerinformation CKD patienter og raske', 'Deltagerinformation PKD patienter', 'Samtykkerklring'). Participants are adults (18–85 years); no assent required.

{"country":"Denmark","full_name":"Aarhus Universitet","duties_or_roles":"sponsorDuties code 1","organisation_type":"Educational Institution"}

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