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Not yet recruitingNCT07820150Updated Sep 15, 2026

Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients

An observational study in Hyperparathyroidism, Secondary, Kidney Failure, Chronic and Chronic Kidney Diseases, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by Assiut University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
130
Ages
18 Years and older
Sex
All
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Study 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 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.

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Conditions studied

  • Hyperparathyroidism, Secondary
  • Kidney Failure, Chronic
  • Chronic Kidney Diseases

Keywords

  • Secondary hyperparathyroidism
  • Dialysis adequacy
  • Hemodialysis
  • Kt/V
  • iPTH
  • Assiut
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In context

Hyperparathyroidism, Secondary

188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.

This study's planned enrollment of 130 is close to the median of 131 across 34 observational studies indexed under Hyperparathyroidism, Secondary.

Browse Hyperparathyroidism, Secondary studies →

Lead sponsor

Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • - Age 18 years or older
  • Diagnosed with end-stage renal disease
  • Maintained on regular thrice-weekly hemodialysis for at least three consecutive months
  • Written

Exclusion criteria

Exclusion Criteria:

  • - Primary hyperparathyroidism or prior parathyroidectomy
  • Active severe infections or acute systemic illnesses
  • Active
  • Severe hepatic dysfunction or chronic liver cirrhosis
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

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Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
130 participants (estimated)
Target follow-up
1 Day
Patient registry
Yes

Groups and cohorts

  • 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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline

Secondary outcomes

  1. 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%.

    Time frame: Baseline

  2. 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.

    Time frame: Baseline

  3. Serum phosphate levels according to dialysis adequacy

    Mean serum phosphate concentration (mg/dL) in patients with adequate versus inadequate dialysis.

    Time frame: Baseline

  4. Serum calcium level

    Mean serum calcium concentration (mg/dL) in patients with secondary hyperparathyroidism.

    Time frame: Baseline

  5. Serum phosphate level

    Mean serum phosphate concentration (mg/dL) in patients with secondary hyperparathyroidism.

    Time frame: Baseline

  6. Serum alkaline phosphatase level

    Mean serum alkaline phosphatase concentration (U/L) in patients with secondary hyperparathyroidism.

    Time frame: Baseline

  7. Calcium-phosphorus product

    Mean calcium-phosphorus product (mg²/dL²) in patients with secondary hyperparathyroidism.

    Time frame: Baseline

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Study locations

No study locations are listed for this record.

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References and documents

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 33813470 ↗
  • Miller 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 28642155 ↗
  • Li 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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07820150
Lead sponsor
Assiut University
Responsible party
Lamia Abdallah fathey (Resident Physician, Assiut University) — Principal investigator
First posted
Sep 15, 2026
Start date
Sep 10, 2026 (estimated)
Primary completion
Sep 10, 2027 (estimated)
Completion
Mar 1, 2028 (estimated)
Last update
Sep 15, 2026

Study contacts

Lamia A fathey, Resident
Contact
lamiaaabdellah62@gmail.com
+20 11 00530550
Salma M Osman, prof
study chair · Internal Medicine Department, Assiut University Hospitals

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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