Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07820150

Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients

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.

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hyperparathyroidism, Secondary Chronic Disease Chronic Kidney Diseases Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hyperparathyroidism Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Parathyroid Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Prevalence of adequate dialysis

    Time frame: Baseline

    Proportion of patients achieving target dialysis adequacy defined as single-pool Kt/V (spKt/V) ≥ 1.2 or urea reduction ratio (URR) ≥ 65%.

  2. Correlation between dialysis adequacy and iPTH level

    Time frame: 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.

  3. Serum phosphate levels according to dialysis adequacy

    Time frame: Baseline

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

  4. Serum calcium level

    Time frame: Baseline

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

  5. Serum phosphate level

    Time frame: Baseline

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

  6. Serum alkaline phosphatase level

    Time frame: Baseline

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

  7. Calcium-phosphorus product

    Time frame: Baseline

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lamia A fathey, Resident

CONTACT

[email protected]

+20 11 00530550

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Sep 15, 2026
Registry last updated
Sep 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.