Hyperphosphatemia in Children With Chronic Kidney Disease

Hyperphosphatemia Clinical Trial

Official title:

Effect of Non-calcium Phosphate Binders Versus Calcium Based Binders on Chronic Kidney Disease -Mineral and Bone Disorder in Children on Regular Hemodialysis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03202407
• Other study ID #: SEVELAMER
• Status: Not yet recruiting
• Phase: Phase 3
• First received: June 20, 2017
• Last updated: June 27, 2017
• Start date: August 1, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: Amed roshdy, professor
• Phone: 01001998013
• Email: ahmedroshdy2[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Progressive renal insufficiency leads to hyperphosphatemia, hypocalcemia, and secondary hyperparathyroidism .

Hyperphosphatemia known as hidden killer in chronic kidney disease defined as an abnormally high serum phosphate concentration of >1.46 mmol/L (4.5 mg/dL). Its long term complications are renal osteodystrophy, hyperparathyroidism, and increased cardiovascular calcification leading to increased mortality and morbidity .

High serum phosphate can interact with calcium to precipitate calcium phosphate salts in non-skeletal tissues Calcification generally occurs in the blood vessels, heart valves, myocardium, and other soft tissues .

Cardiovascular calcification is probably the main reason for the high prevalence of cardiovascular diseases in chronic kidney disease patients Studies have shown that hyperphosphatemia is associated with increased vascular stiffening and arterial and valvular calcification This is postulated to be caused by elevated serum phosphorus promoting the transformation of vascular smooth muscle cells into an osteoblast phenotype that can mineralize These vascular calcification also lead to left ventricular hypertrophy by decreasing vascular compliance . Poor control of mineral metabolism also has been associated with functional and structural cardiac abnormalities Efforts to reduce morbidity and mortality associated with Chronic Kidney Disease-Mineral and Bone Disorder are therefore primarily directed at controlling hyperphosphatemia via diet, phosphorus binders, and dialysis

Dialysis alone is inadequate in assisting hemodialysis patients to obtain and maintain normal serum phosphate levels . So, other methods of achieving prescribed levels of serum phosphate in hemodialysis patients include the use of phosphate binders and phosphorus dietary restrictions.:

Phosphate binders have been approved by the Federal Drug Administration (FDA) for patients treated with maintenance dialysis, and calcium-containing salts are used worldwide not only for the control of hyperphosphatemia but also as a source of supplemental calcium. Several calcium salts are commercially available, including calcium carbonate, calcium acetate, and calcium citrate Sevelamer hydrochloride is a recently developed phosphate binder, which is a quaternary amine anion exchanger without calcium or aluminum. Sevelamer is effective in controlling hyperphosphatemia without increasing the calcium load in chronic hemodialysis patients In addition to its effects on serum phosphorous levels, sevelamer has been shown to decrease total serum cholesterol and low-density lipoprotein cholesterol and to increase high-density lipoprotein levels . These effects may offer additional benefits in reducing cardiovascular complications in patients with end-stage renal disease.

Controlling abnormal laboratory parameters such as calcium ,phosphate and parathyroid hormone as well as preventing the progression of extraskeletal calcification is considered a major component for prevention of the bone disease and other related morbidities and hopefully mortality in chronic kidney disease patients

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 1, 2018
• Est. primary completion date: August 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• - Children < 6 years,

• Severe Gastrointestinal disorder,

• Known hypersensitivity to phosphate binders,

• Inability or rejection to give informed consent,

• Normal serum phosphate level.

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Calcium acetate and sevelamer hydrochloride
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	controlling of hyperphosphatemia	controlling abnormal laboratory parameters such as calcium, phosphate, and parathyroid hormone .	3 months
Primary	Cardiovascular complications	Preventing cardiovascular complication in children with chronic kidney disease	3 months