NCT07820150

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for all trials

Timeline
17mo left

Started Sep 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Sep 2026Mar 2028

First Submitted

Initial submission to the registry

September 9, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

September 10, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 15, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

1 year

First QC Date

September 9, 2026

Last Update Submit

September 11, 2026

Conditions

Hyperparathyroidism, SecondaryChronic Kidney DiseasesKidney Failure, Chronic

Keywords

Secondary hyperparathyroidismDialysis adequacyHemodialysisKt/ViPTHAssiut

Outcome Measures

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.

    Baseline

Secondary Outcomes (7)

  • Prevalence of adequate dialysis

    Baseline

  • Correlation between dialysis adequacy and iPTH level

    Baseline

  • Serum phosphate levels according to dialysis adequacy

    Baseline

  • Serum calcium level

    Baseline

  • Serum phosphate level

    Baseline

  • +2 more secondary outcomes

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \- 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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: 33813470BACKGROUND

  • 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: 28642155BACKGROUND

  • 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: 28646802BACKGROUND

MeSH Terms

Conditions

Hyperparathyroidism, SecondaryKidney Failure, ChronicRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System DiseasesRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Salma M Osman, prof

    Internal Medicine Department, Assiut University Hospitals

    STUDY CHAIR

Central Study Contacts

Lamia A fathey, Resident

CONTACT

+20 11 00530550lamiaaabdellah62@gmail.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Physician

Study Record Dates

First Submitted

September 9, 2026

First Posted

September 15, 2026

Study Start

September 10, 2026

Primary Completion (Estimated)

September 10, 2027

Study Completion (Estimated)

March 1, 2028

Last Updated

September 15, 2026

Record last verified: 2026-09