Last updated: January 5, 2023
Sponsor: First Affiliated Hospital Xi'an Jiaotong University
Overall Status: Active - Recruiting
Phase
N/A
Condition
Hyperparathyroidism
Treatment
N/AClinical Study ID
NCT05549154
XJTU1AF2022LSK-320
Ages 18-90 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age ≥ 18 years.
- Patients with chronic kidney disease stage 5d who have been on haemodialysis for 3months or more
- 5 ng/mL < 25(OH)D < 30 ng/mL (liquid phase tandem mass spectrometry).
- 130 pg/ml < PTH < 600 pg/ml (electrochemiluminescence method).
- serum phosphorus < 1.78 mmol/L.
- Good compliance with the treatment requirements formulated for the study.
- informed consent from the subject.
Exclusion
Exclusion Criteria:
- Patients who are prepped for or have undergone renal transplantation orparathyroidectomy.
- taking vitamin D, active vitamin D or analogues and other drugs that may affect 25(OH)D levels within 3 months prior to enrolment
- Treatment affecting PTH results (e.g. cenacaser, etc.) within 3 months prior toenrolment
- Serum calcium > 2.55 mmol/L
- Patients who are pregnant or likely to become pregnant, breastfeeding or planning tobecome pregnant during the study period
- known prior or concomitant serious illness or medical condition such as malignancy,human immunodeficiency virus, severe gastrointestinal or liver disease, intestinalmalabsorptive disease, hepatitis or cardiovascular events that may worsen or shortenlife expectancy and/or interfere with participation in the study
- History of neurological/psychiatric disease, including psychosis or dementia, or anyother reason that is unlikely to result in adherence to treatment or follow-up plans.
- Known or suspected allergy to any component of the study drug.
- Ongoing participation in other clinical studies.
Study Design
Total Participants: 372
Study Start date:
December 05, 2022
Estimated Completion Date:
October 30, 2023
Connect with a study center
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi'an, Shaanxi 710061
ChinaActive - Recruiting
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