Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients

NCT07820150 — Not yet recruiting, 130 participants, Assiut University

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Prevalence of Hyperparathyroidism Among End-Stage Renal Disease Patients on Regular Hemodialysis and Its Relation to Dialysis Adequacy

RegistryNCT07820150
StatusNot yet recruiting
Study typeObservational
Enrollment130 (Estimated)
SponsorAssiut University (Other)
ConditionsHyperparathyroidism, Secondary, Kidney Failure, Chronic, Chronic Kidney Diseases
Datesstart 2026-09-10 (estimated), primary completion 2027-09-10 (estimated), completion 2028-03-01 (estimated), first posted 2026-09-15, last updated 2026-09-15

Related Papers Related Patents Related Grants Related Experts
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-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Single cohort: ESRD patients on regular hemodialysisAdult 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.

+Outcome measures

Primary outcomes

  • Prevalence of secondary hyperparathyroidism [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.

Secondary outcomes

  • Prevalence of adequate dialysis [Baseline]: Proportion of patients achieving target dialysis adequacy defined as single-pool Kt/V (spKt/V) ≥ 1.2 or urea reduction ratio (URR) ≥ 65%.
  • Correlation between dialysis adequacy and iPTH level [Baseline]: Correlation coefficient between dialysis adequacy parameters (spKt/V and URR) and serum intact parathyroid hormone (iPTH) levels, using Spearman or Pearson correlation as appropriate.
  • Serum phosphate levels according to dialysis adequacy [Baseline]: Mean serum phosphate concentration (mg/dL) in patients with adequate versus inadequate dialysis.
  • Serum calcium level [Baseline]: Mean serum calcium concentration (mg/dL) in patients with secondary hyperparathyroidism.
  • Serum phosphate level [Baseline]: Mean serum phosphate concentration (mg/dL) in patients with secondary hyperparathyroidism.
  • Serum alkaline phosphatase level [Baseline]: Mean serum alkaline phosphatase concentration (U/L) in patients with secondary hyperparathyroidism.
  • Calcium-phosphorus product [Baseline]: Mean calcium-phosphorus product (mg²/dL²) in patients with secondary hyperparathyroidism.

+Eligibility

Sex: All, ages: 18 Years to any

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 informed consent

Exclusion Criteria:

* \- Primary hyperparathyroidism or prior parathyroidectomy
* Active severe infections or acute systemic illnesses
* Active malignancy
* Severe hepatic dysfunction or chronic liver cirrhosis

+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. PMID 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. PMID 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. PMID 28646802

+Investigators