Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05926570 |
| Other study ID # |
36264PR295/8/23 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
August 5, 2023 |
| Est. completion date |
January 22, 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Tanta University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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 pg/ml.
- 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 mg/day 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.
