Ignite Creation Date:
2024-05-06 @ 7:10 PM
Last Modification Date:
2024-10-26 @ 3:02 PM
Study NCT ID:
NCT05926570
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2023-06-07
Brief Title:
Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis
Sponsor:
Tanta University
Organization:
Tanta University
Study Overview
Official Title:
Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Chronic kidney disease CKD is defined as either renal damage and or a glomerular filtration rate GFR below 60 mLmin173 m2 for more than 3 months End stage renal disease ESRD is defined as GFR below 15 mLmin173 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 ie 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
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 ie 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
Detailed Description:
This interventional study will be conducted at Nephrology Unit Pediatric Department Tanta University Hospital TUH for a period of 6 months starting from August 2023
Study duration 6 months from August 2023 to February 2024 Place of the study Nephrology Unit at TUH Study sample This study will be conducted on 35 children and adolescents with end stage renal disease on regular hemodialysis for three to four times weekly at our nephrology Unit at TUH during the period of the study
Inclusion criteria
Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis
Exclusion criteria
Controlled hyperparathyroidism- PTH 300 pgml
Children 8y
Previous parathyroidectomy
children on growth hormone therapy
All patients included in the study will be subjected to
1 History taking including duration of dialysis and regular drugs that are taken
2 Clinical examination including anthropometric measurements and blood pressure estimation All measurements will be taken in the dialysis free day
3 Investigations A- Routine investigations including
Complete blood picture
Serum albumin Serum creatinine blood urea level
Serum CRP B- Specific investigations including
Serum insulin growth factor-1 using ELIZA kits
Serum parathyroid hormone
Serum calcium
Serum phosphorus
Serum alkaline phosphatase
Sample collection
Seven millilitres of venous blood will be collected under complete aseptic precautions at 8 AM and before dialysis session before and after one month of cinacalcet treatment Five millilitres will be put in a plain test tube without anticoagulant and the remaining two millilitres will be put in a test tube with ethylene diamine tetra-acetic acid EDTA as an anticoagulant to be used for performing complete blood count After clotting the samples will be centrifuged at 1500 xg for 15 minutes Part of the separated serum will be used to perform serum creatinine urea albumin and blood urea nitrogen BUN The rest of the serum will be separated and will be used for the subsequent assay of IGF-1 serum level by enzyme-linked immunosorbent assay ELISA Hemolysed samples will be discarded Repeated thawing and freezing will be avoided
4 treatment received All children will receive cinacalcet in a dose of 30 mgday taken with food for 3 months in addition to their supportive treatment including erythropoietin injection oral calcium one alpha folic acid and antihypertensive drugs to hypertensive patients
Study duration 6 months from August 2023 to February 2024 Place of the study Nephrology Unit at TUH Study sample This study will be conducted on 35 children and adolescents with end stage renal disease on regular hemodialysis for three to four times weekly at our nephrology Unit at TUH during the period of the study
Inclusion criteria
Pediatric patients with end stage renal disease aged from 8 to 18 years on regular hemodialysis
Exclusion criteria
Controlled hyperparathyroidism- PTH 300 pgml
Children 8y
Previous parathyroidectomy
children on growth hormone therapy
All patients included in the study will be subjected to
1 History taking including duration of dialysis and regular drugs that are taken
2 Clinical examination including anthropometric measurements and blood pressure estimation All measurements will be taken in the dialysis free day
3 Investigations A- Routine investigations including
Complete blood picture
Serum albumin Serum creatinine blood urea level
Serum CRP B- Specific investigations including
Serum insulin growth factor-1 using ELIZA kits
Serum parathyroid hormone
Serum calcium
Serum phosphorus
Serum alkaline phosphatase
Sample collection
Seven millilitres of venous blood will be collected under complete aseptic precautions at 8 AM and before dialysis session before and after one month of cinacalcet treatment Five millilitres will be put in a plain test tube without anticoagulant and the remaining two millilitres will be put in a test tube with ethylene diamine tetra-acetic acid EDTA as an anticoagulant to be used for performing complete blood count After clotting the samples will be centrifuged at 1500 xg for 15 minutes Part of the separated serum will be used to perform serum creatinine urea albumin and blood urea nitrogen BUN The rest of the serum will be separated and will be used for the subsequent assay of IGF-1 serum level by enzyme-linked immunosorbent assay ELISA Hemolysed samples will be discarded Repeated thawing and freezing will be avoided
4 treatment received All children will receive cinacalcet in a dose of 30 mgday taken with food for 3 months in addition to their supportive treatment including erythropoietin injection oral calcium one alpha folic acid and antihypertensive drugs to hypertensive patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None