Status:
UNKNOWN
Assessing Bone Calcium Content in Children With Kidney Disease Treated With Two Different Medicines
Lead Sponsor:
University College, London
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
5-17 years
Phase:
NA
Brief Summary
This is an open label, time series trial. The trial is likely to be single centre (additional sites will only be opened if necessary) and will involve 25 children with chronic kidney disease (stage 3b...
Detailed Description
Lay Summary of Background and Rationale: The growing bones of children need calcium in order to mineralise (become strong). Children with kidney failure (called chronic kidney disease; CKD) or on dia...
Eligibility Criteria
Inclusion
- Age 5-17 years
- Must be in stable Chronic Kidney Disease (CKD) stage 3b-5 (as per the Kidney Disease Improving Global Outcomes classification) or on dialysis for at least 1 month
- Hyperphosphataemia defined as a serum P above the age-specific normal level as per the Kidney Disease Outcomes Quality Initiative (KDOQI) guideline, or high or normal P levels in a patient already on a P-binder in the preceding 4 weeks
- On a stable Ca and P diet as assessed by a dietitian and willing to avoid intentional changes in their dairy intake during the trial period
- Able to give fully informed consent/ assent as applicable.
Exclusion
- Pre-existing inherited bone disease
- Glucocorticoid therapy in the preceding year, or a lifetime cumulative steroid exposure ≥6 months
- Bisphosphonate therapy at any time in the past
- On cinacalcet in the preceding 6-months
- Any acute illness in the preceding 2 weeks (when the child was unable to maintain their usual diet or had bed-rest)
- Living-donor renal transplant planned ≤6 months
- At screening the albumin-corrected serum calcium cannot be \<2.0mMol/L or \>2.8mMol/L
- Already participating in any interventional clinical trial or last trial completed less than 4 weeks previously
- Previously documented poor compliance with medications
- Any other contraindication to usual prescription of calcium carbonate or sevelamer carbonate
- Any other reason in the opinion of the Investigator that the participant may not be suitable
- Estimated GFR (eGFR) more than 45ml/min/1.73m2
- Pregnant or lactating
- Currently on sevelamer (includes sevelamer carbonate or sevelamer hydrochloride)
Key Trial Info
Start Date :
January 7 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2022
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04120922
Start Date
January 7 2020
End Date
April 1 2022
Last Update
August 12 2021
Active Locations (1)
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1
Great Ormond Street Hospital for Children
London, United Kingdom, WC1N 3JH