Improving Phosphate Control in Children With CKD

NCT05439980 | Unknown

• 1 other identifier: 21BO24
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Research goals: To explore the views and baseline knowledge of children and young people (CYP) with CKD and their caregivers to develop effective phosphate educational materials (PEM), adapted for age, and acknowledging different learning styles

Conditions

Chronic Kidney Diseases; Hyperphosphatemia; Pediatric Kidney Disease; CKD-MBD; Chronic Kidney Disease-Mineral and Bone Disorder

Keywords

Dietary phosphate; Phosphate knowledge questionnaire

Outcome Measures

Primary Outcomes (2)

• Characterise the facilitators and barriers to adherence to reduced dietary phosphate advice and phosphate binder medication administration in children and young people with CKD and their caregivers.

  Qualitative - questionnaire and focus groups

  2 years

• Identify the preferred format and content of phosphate educational material of children and young people with CKD

  Questionnaire and focus groups

  2 years

Study Arms (3)

CKD aged 8-<13 years

8-\<13 years n = 25

Other: Knowledge questionnaire; Other: Focus groups

CKD aged 13-18 years

13-18 years n = 25

Other: Knowledge questionnaire; Other: Focus groups

Parents/caregivers

Parent/caregivers of children and young people with CKD 4-5D n=50

Other: Knowledge questionnaire; Other: Focus groups

Interventions

Knowledge questionnaire OTHER

Completion of a questionnaire at baseline

CKD aged 13-18 years; CKD aged 8-<13 years; Parents/caregivers

Focus groups OTHER

structured interviews

CKD aged 13-18 years; CKD aged 8-<13 years; Parents/caregivers

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

50 caregiver-child dyads with CKD stage 4-5 and on dialysis

You may qualify if:

• Patients with CKD4-5D between 8-18 years of age.
• One caregiver per patient.
• Consenting to study.

You may not qualify if:

• Children with neurodevelopmental or cognitive disorders.
• Children with an underlying phosphate-losing disease.
• Children on intensive dialysis regimens such as home haemodialysis or frequent daily in-centre HD.
• Children who are fully enterally tube fed.
• Children or caregivers with limited spoken or written language skills.

Sponsors & Collaborators

• Great Ormond Street Hospital for Children NHS Foundation Trust: lead

Study Sites (1)

Great Ormond Street Hospital for Children

London, WC1N3JH, United Kingdom

RECRUITING

Related Publications (10)

• Palmer SC, Hayen A, Macaskill P, Pellegrini F, Craig JC, Elder GJ, Strippoli GF. Serum levels of phosphorus, parathyroid hormone, and calcium and risks of death and cardiovascular disease in individuals with chronic kidney disease: a systematic review and meta-analysis. JAMA. 2011 Mar 16;305(11):1119-27. doi: 10.1001/jama.2011.308.

  PMID: 21406649 BACKGROUND

• Shroff R, Long DA, Shanahan C. Mechanistic insights into vascular calcification in CKD. J Am Soc Nephrol. 2013 Feb;24(2):179-89. doi: 10.1681/ASN.2011121191. Epub 2012 Nov 8.

  PMID: 23138485 BACKGROUND

• Bertram JF, Goldstein SL, Pape L, Schaefer F, Shroff RC, Warady BA. Kidney disease in children: latest advances and remaining challenges. Nat Rev Nephrol. 2016 Mar;12(3):182-91. doi: 10.1038/nrneph.2015.219. Epub 2016 Feb 1.

  PMID: 26831913 BACKGROUND

• Kidney Disease: Improving Global Outcomes (KDIGO) CKD-MBD Update Work Group. KDIGO 2017 Clinical Practice Guideline Update for the Diagnosis, Evaluation, Prevention, and Treatment of Chronic Kidney Disease-Mineral and Bone Disorder (CKD-MBD). Kidney Int Suppl (2011). 2017 Jul;7(1):1-59. doi: 10.1016/j.kisu.2017.04.001. Epub 2017 Jun 21. No abstract available.

  PMID: 30675420 BACKGROUND

• McAlister L, Pugh P, Greenbaum L, Haffner D, Rees L, Anderson C, Desloovere A, Nelms C, Oosterveld M, Paglialonga F, Polderman N, Qizalbash L, Renken-Terhaerdt J, Tuokkola J, Warady B, Walle JV, Shaw V, Shroff R. The dietary management of calcium and phosphate in children with CKD stages 2-5 and on dialysis-clinical practice recommendation from the Pediatric Renal Nutrition Taskforce. Pediatr Nephrol. 2020 Mar;35(3):501-518. doi: 10.1007/s00467-019-04370-z. Epub 2019 Oct 30.

  PMID: 31667620 BACKGROUND

• Farfan-Ruiz AC, Czikk D, Leidecker J, Ramsay T, McCormick B, Wilson K, Zimmerman D. Multidisciplinary Team versus a "Phosphate-Counting" App for Serum Phosphate Control: A Randomized Controlled Trial. Kidney360. 2020 Dec 15;2(2):290-297. doi: 10.34067/KID.0007132020. eCollection 2021 Feb 25.

  PMID: 35373021 BACKGROUND

• Karamanidou C, Clatworthy J, Weinman J, Horne R. A systematic review of the prevalence and determinants of nonadherence to phosphate binding medication in patients with end-stage renal disease. BMC Nephrol. 2008 Jan 31;9:2. doi: 10.1186/1471-2369-9-2.

  PMID: 18237373 BACKGROUND

• Hyperphosphataemia in chronic kidney disease: Evidence Update December 2014: A summary of selected new evidence relevant to NICE clinical guideline 157 'Management of hyperphosphataemia in patients with stage 4 or 5 chronic kidney disease' (2013) [Internet]. London: National Institute for Health and Care Excellence (NICE); 2014. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK552051/

  PMID: 31886981 BACKGROUND

• Abercrombie EL, Greenbaum LA, Baxter DH, Hopkins B. Effect of intensified diet education on serum phosphorus and knowledge of pediatric peritoneal dialysis patients. J Ren Nutr. 2010 May;20(3):193-8. doi: 10.1053/j.jrn.2009.10.011. Epub 2010 Mar 19.

  PMID: 20303791 BACKGROUND

• Ahlenstiel T, Pape L, Ehrich JH, Kuhlmann MK. Self-adjustment of phosphate binder dose to meal phosphorus content improves management of hyperphosphataemia in children with chronic kidney disease. Nephrol Dial Transplant. 2010 Oct;25(10):3241-9. doi: 10.1093/ndt/gfq161. Epub 2010 Mar 22.

  PMID: 20308040 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia; Chronic Kidney Disease-Mineral and Bone Disorder

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Rickets; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Calcium Metabolism Disorders; Vitamin D Deficiency; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Hyperparathyroidism, Secondary; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Louise McAlister, BSc (Hons)

CONTACT

07810720600; louise.mcalister@gosh.nhs.uk

Rukshana Shroff

CONTACT

02078138513; Rukshana.shroff@gosh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 27, 2022
• First Posted: June 30, 2022
• Study Start: June 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: November 30, 2024
• Last Updated: November 15, 2023

Record last verified: 2023-11

Locations

GB (1)