Hyperphosphatemia in Children With Chronic Kidney Disease
Effect of Non-calcium Phosphate Binders Versus Calcium Based Binders on Chronic Kidney Disease -Mineral and Bone Disorder in Children on Regular Hemodialysis
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
"Chronic Kidney Disease-Mineral and Bone Disorder " is a systemic disorder of mineral and bone metabolism, due to chronic kidney disease that is manifested by either one or a combination of the following :
- 1.Abnormalities of calcium, phosphate, parathyroid hormone or vitamin D metabolism
- 2.Vascular and/or soft tissue calcification.
- 3.Abnormalities in bone turnover, metabolism, volume, linear growth or strength. According to glomerular filtration rate , Kidney Disease Improving Global Outcomesclassify chronic kidney disease into 5 stages,stage 5 also known as End Stage Renal disease is defined as glomerular filtration rate less than 15 ml/Min/1.73 m2, or the need for renal replacement therapy for survival The kidney plays a major role in phosphate homoeostasis. The kidneys excrete the total net amount of absorbed phosphate.Under normal physiological condition phosphate is freely filtered through the glomerulus. The majority (85-90%) of filtered phosphate undergoes tubular reabsorption primarily in proximal tubules.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Aug 2017
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 20, 2017
CompletedFirst Posted
Study publicly available on registry
June 28, 2017
CompletedStudy Start
First participant enrolled
August 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedJune 28, 2017
June 1, 2017
1 year
June 20, 2017
June 27, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
controlling of hyperphosphatemia
controlling abnormal laboratory parameters such as calcium, phosphate, and parathyroid hormone .
3 months
Cardiovascular complications
Preventing cardiovascular complication in children with chronic kidney disease
3 months
Study Arms (2)
calcium group
PLACEBO COMPARATORwill receive calcium-based phosphate binder (calcium carbonate ) 45-65 mg/kg orally divided 3 to 4 times/day for 3 months. all the following investigation will be done before and after consecutive 3 months of administration : * Complete blood count * Kidney function tests (serum urea and creatinine) * Serum total calcium level. * Serum phosphorus level. * Calcium × phosphorus product. * Serum parathormone level. * Serum alkaline phosphatase level. * Lipogram (Total cholesterol, High density lipoprotein, Low density lipoprotein and triglycerides). * Echocardiography regular follow up of serum phosphate , calcium and parathyroid hormone will be done every month for dose adjustment of the drug
sevelamer group
EXPERIMENTALwill receive the recommended daily dose of the Sevelamer hydrochloride phosphate binder 120-160 mg/kg orally 3 times per day for 3 months. all the following investigation will be done before and after consecutive 3 months of administration : * Complete blood count * Kidney function tests (serum urea and creatinine) * Serum total calcium level. * Serum phosphorus level. * Calcium × phosphorus product. * Serum parathormone level. * Serum alkaline phosphatase level. * Lipogram (Total cholesterol, High density lipoprotein, Low density lipoprotein and triglycerides). * Echocardiography regular follow up of serum phosphate , calcium and parathyroid hormone will be done every month for dose adjustment of the drug
Interventions
receive the conventional renal replacement therapy including calcium-based phosphate (calcium acetate) and active form of vitamin D for 3 months with regular follow up of serum phosphate ,calcium, parathyroid hormone and alkaline phosphate every month
Eligibility Criteria
You may qualify if:
- Children aged from 6 to 18 years
- With end stage renal disease on regular hemodialysis,
- With hyperphosphatemia (serum phosphorus \> 4.5mg/dL ).
- Both genders will be included
- Given informed concent.
You may not qualify if:
- \- Children \< 6 years,
- Severe Gastrointestinal disorder,
- Known hypersensitivity to phosphate binders,
- Inability or rejection to give informed consent,
- Normal serum phosphate level.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- single blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- pediatrition
Study Record Dates
First Submitted
June 20, 2017
First Posted
June 28, 2017
Study Start
August 1, 2017
Primary Completion
August 1, 2018
Study Completion
December 1, 2018
Last Updated
June 28, 2017
Record last verified: 2017-06