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Impact on Neurocognitive Performance in Children, Adolescents and Young Adults of Chronic Kidney Disease and its Therapy: A Feasibility Study.

Impact on Neurocognitive Performance in Children, Adolescents and Young Adults of Chronic Kidney Disease and its Therapy: A Feasibility Study. - The INPACT: a feasibility study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON47563
Enrollment
40
Registered
2018-09-28
Start date
2017-06-16
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease familial uremia kidney failure

Interventions

brain networks
cognitive impairments
Renal transplantation

Sponsors

Amsterdam UMC locatie AMC
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

Inclusion criteria: Inclusioncriteria for patients with CKD: * Patients with CKD 4-5/ESRD or ESRD patients who underwent renal transplantation at least one years ago. * aged 8-30 years. * Sufficient visual and hearing acuity * Dutch language fluency * Willingness to give informed consent;Inclusioncriteria for three patients with familial uremia: * Diagnosis of familial uremia. * age 12 to 50 years * Sufficient visual and hearing acuity * Dutch language fluency * Willingness to give informed consent;Healthy controls must meet all of the following criteria * Sibling of the candidate, healthy classmate or close friend of the CKD patient. * No diagnosis of CKD, or other chronic disease with primary or secondary CNS involvement * Informed consent obtained from the participant or legal guardian if the participant is below 18 years * age 8-30 year * Sufficient visual and hearing acuity * Dutch language fluency * Willingness to give informed consent

Exclusion criteria

Exclusion criteria: For both patients and healthy controls: * Pre-existing documented cognitive impairment * Active, uncontrolled psychiatric illness * Substance abuse * A history of cerebrovascular disease (either transitory ischaemic attack or cerebrovascular accident) * Brain injury * Epilepsy * Diabetes mellitus * Patients will be excluded from MRI scanning in case of MR contraindications, including implanted active devices or objects (e.g. cardiac pacemaker, implantable defibrillator, medication pump, intracranial aneurysm clips, cochlear implant and other implants), metal splinters near sensitive organs (e.g. eye, brain or lungs) or claustrophobia. They are eligible to participate in the other measurements of the study protocol. * Any condition that can be expected to interfere with complete follow-up * Patients participating in group 1 of the ALLEGRO trial (adult patients) * HLA-identical family transplantations

Design outcomes

Primary

MeasureTime frame
The main study outcome of the current study is relevance, feasibility and strain for patients of the INPACT protocol, as felt by the participants themselves (and as perceived by their parents too, for children

Secondary

MeasureTime frame
Neurocognitive functioning will be assessed by neuropsychological test administration. Medical parameters are derived from the medical records. Brain structure and activity will be measured with MRI-scans (including DTI) and qEEG recording. Adaptive functioning, behavior, health perception, quality of life, sleep and sociodemographic background will be assessed by a variety of questionnaires.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)