Drug EffectPhase 4NCT05926570
Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis
A Phase 4 study testing Cinacalcet in people with Drug Effect, run by Tanta University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Drug Effect
- What is being tested?
- Cinacalcet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Aug 2023to 22 Jan 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis.
Who cannot join
- Controlled hyperparathyroidism- PTH <300 pg/ml.
- Children < 8y.
- Previous parathyroidectomy
- children on growth hormone therapy
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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 pg/ml.
- Children < 8y.
- Previous parathyroidectomy
- children on growth hormone therapy
All patients included in the study will be subjected to:
- History taking including duration of dialysis and regular drugs that are taken.
- Clinical examination including anthropometric measurements and blood pressure estimation. All measurements will be taken in the dialysis free day
- 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.
- 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.
- Conditions
- Drug Effect
- Being tested
- Cinacalcet
- Keywords
- cinacalcet, insulin like growth factor-1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CinacalcetDrug
Also called Mimpara
calcimimetic
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Secondary outcomes (1)
Cinacalcet effect on level of IGF-1
cinacalcet will be given in a dose of 39mg/day with food for 3 months
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start5 Aug 2023
- Primary completion22 Jan 2024
- Study completion22 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug EffectStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- evaluate the effect of cinacalcet on insulin like growth factor-1 in pediatric patients with ESRD on regular hemodialysis
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Mabrouk Elghoul, Tanta University
- Investigators
- Sara Mabrouk Mohamed Elghoul, MD, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05926570
- Sponsor's protocol ID
- 36264PR295/8/23
- Status last verified
- Jan 2024
- First submitted
- 7 Jun 2023
- Last updated
- 24 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parathyroid Hormone Level and Growth in Pediatric Patients With ESRD on Regular Hemodialysis
- ClinicalTrials.gov ID
- NCT05926570
- Acronym / sponsor ID
- 36264PR295/8/23
- Conditions
- Drug Effect
- Keywords
- cinacalcet, insulin like growth factor-1
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 5 Aug 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 22 Jan 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 pg/ml.
- Children < 8y.
- Previous parathyroidectomy
- children on growth hormone therapy
All patients included in the study will be subjected to:
- History taking including duration of dialysis and regular drugs that are taken.
- Clinical examination including anthropometric measurements and blood pressure estimation. All measurements will be taken in the dialysis free day
- 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.
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- evaluate the effect of cinacalcet on insulin like growth factor-1 in pediatric patients with ESRD on regular hemodialysis
| Arm | Type | Receives |
|---|---|---|
| 35 children and adolescents with end stage renal disease on regular hemodialysis | Experimental | Drug: CinacalcetAll children will receive cinacalcet in a dose of 30 mg/day taken with food for 3 months |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pediatric patients with end stage renal disease aged from 5 to 18 years on regular hemodialysis.
Key exclusion criteria (4 listed)
- Controlled hyperparathyroidism- PTH <300 pg/ml.
- Children < 8y.
- Previous parathyroidectomy
- children on growth hormone therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CinacalcetAlso: Mimparacalcimimetic | Drug | 35 children and adolescents with end stage renal disease on regular hemodialysis |
Primary outcome
correlation between PTH and serum IGF-1
Time frame: 3 months
correlation between serum levels of parathyroid hormone and serum insulin like growth factor-1 in pediatric patients with ESRD on regular hemodialysis
1 secondary outcome
Cinacalcet effect on level of IGF-1
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sara Mabrouk Mohamed Elghoul, MD principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Cinacalcet in people with Drug Effect, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between PTH and serum IGF-1 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2024.