Hongli Jiang, Professor

CONTACT

Lead Sponsor

First Affiliated Hospital Xi'an Jiaotong University

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

No

•1. Age ≥ 18 years.
•2. Patients with chronic kidney disease stage 5d who have been on haemodialysis for 3 months or more
•3. 5 ng/mL \< 25(OH)D \< 30 ng/mL (liquid phase tandem mass spectrometry).
•4. 130 pg/ml \< PTH \< 600 pg/ml (electrochemiluminescence method).
•5. serum phosphorus \< 1.78 mmol/L.
•6. Good compliance with the treatment requirements formulated for the study.
•7. informed consent from the subject.

•1. Patients who are prepped for or have undergone renal transplantation or parathyroidectomy.
•2. taking vitamin D, active vitamin D or analogues and other drugs that may affect 25(OH)D levels within 3 months prior to enrolment
•3. Treatment affecting PTH results (e.g. cenacaser, etc.) within 3 months prior to enrolment
•4. Serum calcium \> 2.55 mmol/L
•5. Patients who are pregnant or likely to become pregnant, breastfeeding or planning to become pregnant during the study period
•6. known prior or concomitant serious illness or medical condition such as malignancy, human immunodeficiency virus, severe gastrointestinal or liver disease, intestinal malabsorptive disease, hepatitis or cardiovascular events that may worsen or shorten life expectancy and/or interfere with participation in the study
•7. History of neurological/psychiatric disease, including psychosis or dementia, or any other reason that is unlikely to result in adherence to treatment or follow-up plans.
•8. Known or suspected allergy to any component of the study drug.
•9. Ongoing participation in other clinical studies.