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NCT06449729 Clinical Trial

Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism

Hypoparathyroidism Clinical Trial

— ENDORSE  

Official title:
Endocrine Determinants of Renal Function in Patients With Hypoparathyroidism on Conventional Treatment: a Cross-sectional Study

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06449729
Other study ID # BP 11006333
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 28, 2022
Est. completion date April 28, 2023

Study information
Verified date March 2024
Source IRCCS San Raffaele
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Endocrine determinants of renal function in patients with hypoparathyroidism on conventional treatment: a cross-sectional study (ENDORSE)

Recruitment information / eligibility
Status Completed
Enrollment 46
Est. completion date April 28, 2023
Est. primary completion date April 28, 2023
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age = 18 years - diagnosis of chronic (= 1 year) post-surgical and autoimmune hypoparathyroidism, as established with undetectable or insufficient PTH concentration in relation to the presence of hypocalcemia - patients being treated with calcitriol or alfacalcidiol - patients able to sign the written informed consent Exclusion Criteria: - pregnancy - severe renal failure requiring dialysis treatment - macroproteinuria - use of antihypertensive drugs such as thiazides, ACE inhibitors, sartans, beta and alpha blockers, and antialdosterone drugs - pazients affected by diabetes mellitus- insulin-treated

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood sample and urine collection
Blood sample and urine collection as per clinical practice

Locations
Country Name City State
Italy Andrea Giustina Milan

Sponsors (1)
Lead Sponsor Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary The rate of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism Evaluation of the prevalence of renal failure and altered PTH-related renal active hormonal axis in patients with hypoparathyroidism (hypoPTH) in conventional treatment with calcium and vitamin D 12 months
See also
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Active, not recruiting NCT05965167 - Assess Safety and Compare PK of New Oral hPTH(1-34) Tablet Formulations vs. EBP05 Tablets and Subcutaneous Forteo Phase 1/Phase 2
Recruiting NCT02986607 - Corticosteroid Rhythms in Hypoparathyroid Patients Early Phase 1
Completed NCT00793689 - Perioperative Parathormone Measurement and Sodium Bicarbonate Infusion Test After Total Thyroidectomy N/A