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

Completed

• Conditions: chronic kidney disease; familial uremia; kidney failure; 10038430

• Registration Number: NL-OMON47563
• Lead Sponsor: Amsterdam UMC locatie AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

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

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

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study outcome of the current study is relevance, feasibility and<br /><br>strain for patients of the INPACT protocol, as felt by the participants<br /><br>themselves (and as perceived by their parents too, for children < 18 years of<br /><br>age). Semi-structured interviews will be conducted by telephone to collect<br /><br>these data.<br /><br>We will also systematically record: the number of approached patients who<br /><br>declined participation, reasons for non-participation, and % completion of the<br /><br>study protocol by participants (completion and response rates).<br /><br>Based on these data, feasibility for enrolment of sufficiently large samples<br /><br>for the intervention study (the INPACT study) will be determined and the study<br /><br>protocol will adjusted if necessary. </p><br>

Secondary Outcome Measures

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