Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis

NCT05926570 | Completed Phase 4

• 1 other identifier: 36264PR295/8/23
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic kidney disease (CKD) is defined as either renal damage and/ or a glomerular filtration rate (GFR) below 60 mL/min/1.73 m2 for more than 3 months. End stage renal disease (ESRD) is defined as GFR below 15 mL/min/1.73 m2. Secondary hyperparathyroidism (SHPT) is an insidious disease that develops early in the course of CKD and increase in severity as the GFR deteriorates. High serum levels of intact parathyroid hormone (iPTH) are known to cause high turnover bone disease, i.e. osteitis fibrosa and have also been reported to increase the mortality risk in patients undergoing hemodialysis (HD). Standard therapy for SHPT includes dietary calcium supplementation, active vitamin D, and phosphate binders; however, these are often insufficient to allow patients to achieve their serum parathyroid hormone (PTH), calcium and calcium-phosphorus product (Ca × P) targets. Recent preclinical studies have demonstrated that treatment with calcimimetics that increase the sensitivity of the calcium-sensing receptor (CaR) to calcium can reverse the alterations in CaR and vitamin D receptor expression and parathyroid cell proliferation that are associated with SHPT. Calcimimetics such as cinacalect are positive allosteric modulators of the calcium-sensing receptor that increase its sensitivity by lowering the threshold for activation by extracellular calcium ions. The calcimimetic cinacalcet mainly increases the sensitivity of the CaR to extracellular Ca, thus inhibiting the release of PTH, although, as recently shown, it also decreases PTH synthesis. Growth hormone (GH) indirectly promotes the growth of child by stimulating the production of insulin like growth factor (IGF-1), many children with renal disease have normal or elevated level of GH in their blood otherwise the levels of IGF-1 are low because the approximately 98% of IGF-1 is always bound to one of binding proteins (BP) inside the liver, so this accumulated protein will reduce the function of IGF-1. Using cinacalcet in controlling hyperparathyroidism may reduce growth problems in children with ESRD with regular hemodialysis.

Conditions

Drug Effect

Keywords

cinacalcet; insulin like growth factor-1

Outcome Measures

Primary Outcomes (1)

• correlation between PTH and serum IGF-1

  correlation between serum levels of parathyroid hormone and serum insulin like growth factor-1 in pediatric patients with ESRD on regular hemodialysis

  3 months

Secondary Outcomes (1)

• Cinacalcet effect on level of IGF-1

  3 months

Study Arms (1)

35 children and adolescents with end stage renal disease on regular hemodialysis

EXPERIMENTAL

All children will receive cinacalcet in a dose of 30 mg/day taken with food for 3 months

Drug: Cinacalcet

Interventions

Cinacalcet DRUG

calcimimetic

Also known as: Mimpara

35 children and adolescents with end stage renal disease on regular hemodialysis

Eligibility Criteria

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

You may qualify if:

• Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis.

You may not qualify if:

• Controlled hyperparathyroidism- PTH \<300 pg/ml.
• Children \< 8y.
• Previous parathyroidectomy
• children on growth hormone therapy

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Sara Mabrouk Mohamed Elghoul

Tanta, Egypt

Location

MeSH Terms

Interventions

Cinacalcet

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Sara Mabrouk Mohamed Elghoul, MD

  Tanta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Lecturer of Pediatric Nephrology

Model Details: evaluate the effect of cinacalcet on insulin like growth factor-1 in pediatric patients with ESRD on regular hemodialysis

Study Record Dates

• First Submitted: June 7, 2023
• First Posted: July 3, 2023
• Study Start: August 5, 2023
• Primary Completion: January 22, 2024
• Study Completion: January 22, 2024
• Last Updated: January 24, 2024

Record last verified: 2024-01

Locations

EG (1)