Hyperparathyroidism, SecondaryNCT07820150
Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients
An observational study of Hyperparathyroidism, Secondary and Kidney Failure, Chronic, run by Assiut University.
Trial summary
This cross-sectional study aims to determine the prevalence of secondary hyperparathyroidism among end-stage renal disease patients on regular hemodialysis and to evaluate its relationship with dialysis adequacy at Assiut University Hospitals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Chronic Kidney Diseases
- How many people
- 130 participants
- Where
- No sites listed yet
- Study dates
- 10 Sep 2026to 1 Mar 2028
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with end-stage renal disease maintained on regular thrice-weekly hemodialysis for at least three months at the Hemodialysis Unit, Nephrology Department, Assiut University Hospitals.
Who may be able to join
- - Age 18 years or older
- Diagnosed with end-stage renal disease
- Maintained on regular thrice-weekly hemodialysis for at least three consecutive months
- Written informed consent
Who cannot join
- - Primary hyperparathyroidism or prior parathyroidectomy
- Active severe infections or acute systemic illnesses
- Active malignancy
- Severe hepatic dysfunction or chronic liver cirrhosis
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prevalence of Hyperparathyroidism Among End-Stage Renal Disease Patients on Regular Hemodialysis and Its Relation to Dialysis Adequacy
This cross-sectional study aims to determine the prevalence of secondary hyperparathyroidism among end-stage renal disease patients on regular hemodialysis and to evaluate its relationship with dialysis adequacy at Assiut University Hospitals.
Read the detailed description
Secondary hyperparathyroidism is a common complication of end-stage renal disease and is associated with bone disease, vascular calcification, and increased mortality. Dialysis adequacy, measured by spKt/V and urea reduction ratio (URR), may influence phosphate control and parathyroid hormone levels.
This observational cross-sectional study will include adult patients with end-stage renal disease maintained on regular thrice-weekly hemodialysis for at least three months. Dialysis adequacy will be assessed by spKt/V and URR. Serum intact parathyroid hormone (iPTH) and mineral parameters will be measured.
- Keywords
- Secondary hyperparathyroidism, Dialysis adequacy, Hemodialysis, Kt/V, iPTH, Assiut
- Medical subject headings
- Hyperparathyroidism, Secondary, Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Single cohort: ESRD patients on regular hemodialysis | Adult patients with end-stage renal disease on regular thrice-weekly hemodialysis who will undergo assessment of dialysis adequacy (spKt/V and URR) and measurement of serum intact parathyroid hormone and mineral parameters. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of secondary hyperparathyroidism
Proportion of patients with elevated intact parathyroid hormone (iPTH) levels above the target range (greater than 9 times the upper limit of normal) among regular hemodialysis patients.
Measured: Baseline
Secondary outcomes (7)
Prevalence of adequate dialysis
Proportion of patients achieving target dialysis adequacy defined as single-pool Kt/V (spKt/V) ≥ 1.2 or urea reduction ratio (URR) ≥ 65%.
Measured: Baseline
Correlation between dialysis adequacy and iPTH level
Correlation coefficient between dialysis adequacy parameters (spKt/V and URR) and serum intact parathyroid hormone (iPTH) levels, using Spearman or Pearson correlation as appropriate.
Measured: Baseline
Serum phosphate levels according to dialysis adequacy
Mean serum phosphate concentration (mg/dL) in patients with adequate versus inadequate dialysis.
Measured: Baseline
Serum calcium level
Mean serum calcium concentration (mg/dL) in patients with secondary hyperparathyroidism.
Measured: Baseline
Serum phosphate level
Mean serum phosphate concentration (mg/dL) in patients with secondary hyperparathyroidism.
Measured: Baseline
Serum alkaline phosphatase level
Mean serum alkaline phosphatase concentration (U/L) in patients with secondary hyperparathyroidism.
Measured: Baseline
Calcium-phosphorus product
Mean calcium-phosphorus product (mg²/dL²) in patients with secondary hyperparathyroidism.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2026
- Study start10 Sep 2026 (estimated)
- Primary completion10 Sep 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Hyperparathyroidism, SecondaryStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 130 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lamia Abdallah fathey, Assiut University
- Investigators
- Salma M Osman, prof, Study chair, Internal Medicine Department, Assiut University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07820150
- Sponsor's protocol ID
- HPT-HD-Adequacy-Assiut-2026
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gubina-Vakulik GI, Belyaev SG, Doroganova OV, Nestertsova NS, Fedota OM, Belyaeva IS. HYPODYNAMIA AS A FACTOR MODIFYING FUNCTIONAL MORPHOLOGY OF HUMAN PLACENTA. Wiad Lek. 2021;74(2):190-195.
PubMed 33813470Miller MA, Yu F, Kim KI, Kasting GB. Uptake and desorption of hydrophilic compounds from human stratum corneum. J Control Release. 2017 Sep 10;261:307-317. doi: 10.1016/j.jconrel.2017.06.015. Epub 2017 Jun 19.
PubMed 28642155Li D, Huachong X, Peng P, Ke Z, Jiao N, Xianlin W, Bin Y, Jia C, Xiaoyin C. Dampness Can Promote the Influenza A Virus and Worsen Its Prognosis by Upregulating the TLR7 Signaling Pathway. Altern Ther Health Med. 2017 Nov;23(6):16-22.
PubMed 28646802
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Hyperparathyroidism Among End-Stage Renal Disease Patients on Regular Hemodialysis and Its Relation to Dialysis Adequacy
- ClinicalTrials.gov ID
- NCT07820150
- Acronym / sponsor ID
- HPT-HD-Adequacy-Assiut-2026
- Keywords
- Secondary hyperparathyroidism, Dialysis adequacy, Hemodialysis, Kt/V, iPTH, Assiut
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 10 Sep 2026 (estimated)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 15 Sep 2026 (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.
This cross-sectional study aims to determine the prevalence of secondary hyperparathyroidism among end-stage renal disease patients on regular hemodialysis and to evaluate its relationship with dialysis adequacy at Assiut University Hospitals.
Detailed description
Secondary hyperparathyroidism is a common complication of end-stage renal disease and is associated with bone disease, vascular calcification, and increased mortality. Dialysis adequacy, measured by spKt/V and urea reduction ratio (URR), may influence phosphate control and parathyroid hormone levels.
This observational cross-sectional study will include adult patients with end-stage renal disease maintained on regular thrice-weekly hemodialysis for at least three months. Dialysis adequacy will be assessed by spKt/V and URR. Serum intact parathyroid hormone (iPTH) and mineral parameters will be measured.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single cohort: ESRD patients on regular hemodialysis | – | –Adult patients with end-stage renal disease on regular thrice-weekly hemodialysis who will undergo assessment of dialysis adequacy (spKt/V and URR) and measurement of serum intact parathyroid hormone and mineral parameters. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with end-stage renal disease maintained on regular thrice-weekly hemodialysis for at least three months at the Hemodialysis Unit, Nephrology Department, Assiut University Hospitals.
Key inclusion criteria (4 listed)
- - Age 18 years or older
- Diagnosed with end-stage renal disease
- Maintained on regular thrice-weekly hemodialysis for at least three consecutive months
- Written informed consent
Key exclusion criteria (4 listed)
- - Primary hyperparathyroidism or prior parathyroidectomy
- Active severe infections or acute systemic illnesses
- Active malignancy
- Severe hepatic dysfunction or chronic liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of secondary hyperparathyroidism
Time frame: Baseline
Proportion of patients with elevated intact parathyroid hormone (iPTH) levels above the target range (greater than 9 times the upper limit of normal) among regular hemodialysis patients.
7 secondary outcomes
Prevalence of adequate dialysis
Time frame: Baseline
Correlation between dialysis adequacy and iPTH level
Time frame: Baseline
Serum phosphate levels according to dialysis adequacy
Time frame: Baseline
Serum calcium level
Time frame: Baseline
Serum phosphate level
Time frame: Baseline
Serum alkaline phosphatase level
Time frame: Baseline
Calcium-phosphorus product
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Background: PubMed 33813470Gubina-Vakulik GI, Belyaev SG, Doroganova OV, Nestertsova NS, Fedota OM, Belyaeva IS. HYPODYNAMIA AS A FACTOR MODIFYING FUNCTIONAL MORPHOLOGY OF HUMAN PLACENTA. Wiad Lek. 2021;74(2):190-195.
- Background: PubMed 28642155Miller MA, Yu F, Kim KI, Kasting GB. Uptake and desorption of hydrophilic compounds from human stratum corneum. J Control Release. 2017 Sep 10;261:307-317. doi: 10.1016/j.jconrel.2017.06.015. Epub 2017 Jun 19.
- Background: PubMed 28646802Li D, Huachong X, Peng P, Ke Z, Jiao N, Xianlin W, Bin Y, Jia C, Xiaoyin C. Dampness Can Promote the Influenza A Virus and Worsen Its Prognosis by Upregulating the TLR7 Signaling Pathway. Altern Ther Health Med. 2017 Nov;23(6):16-22.
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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.
Salma M Osman, prof study chair
Internal Medicine Department, Assiut University Hospitals
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperparathyroidism, Secondary and Kidney Failure, Chronic, run by Assiut University.
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 4 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: opening soon, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lamia A fathey, Resident (+20 11 00530550, lamiaaabdellah62@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of secondary hyperparathyroidism (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07820150, which also lists 3 linked publications.
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 15 Sep 2026.