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Hyperparathyroidism and Dialysis Adequacy in Hemodialysis Patients

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07820150
Enrollment
130
Registered
2026-09-15
Start date
2026-09-10
Completion date
2028-03-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Secondary hyperparathyroidism, Dialysis adequacy, Hemodialysis, Kt/V, iPTH, Assiut

Brief 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.

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.

Interventions

None listed

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of secondary hyperparathyroidismBaselineProportion 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

MeasureTime frameDescription
Prevalence of adequate dialysisBaselineProportion 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 levelBaselineCorrelation 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 adequacyBaselineMean serum phosphate concentration (mg/dL) in patients with adequate versus inadequate dialysis.
Serum calcium levelBaselineMean serum calcium concentration (mg/dL) in patients with secondary hyperparathyroidism.
Serum phosphate levelBaselineMean serum phosphate concentration (mg/dL) in patients with secondary hyperparathyroidism.
Serum alkaline phosphatase levelBaselineMean serum alkaline phosphatase concentration (U/L) in patients with secondary hyperparathyroidism.
Calcium-phosphorus productBaselineMean calcium-phosphorus product (mg²/dL²) in patients with secondary hyperparathyroidism.

Contacts

CONTACTLamia A fathey, Resident
lamiaaabdellah62@gmail.com+20 11 00530550
STUDY_CHAIRSalma M Osman, prof

Internal Medicine Department, Assiut University Hospitals

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026