Secondary Hyperparathyroidism
Conditions
Interventions
Test group:NT-002 Capsules(oral use)
Control group:Placebo(oral use)
Sponsors
The First Affiliated Hospital of Dalian Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged >= 18 years at the time of signing the ICF. 2. Subjects who have voluntarily signed the informed consent form (ICF) and be able to follow the protocol-specified visit schedule during the trial. 3. Patients with SHPT as diagnosed by the Investigator. 4. Stage 3 (eGFR >= 30 and =15 and = 85 pg/mL and = 8.4 mg/dL (2.10 mmol/L) and = 2.0 mg/dL (0.65 mmol/L) and = 10 ng/mL and <30 ng/mL.
Exclusion criteria
Exclusion criteria: 1. Patients with a history of kidney transplant or parathyroidectomy 2. Patients receiving vitamin D (ergocalciferol or cholecalciferol) at doses > 1600 IU/day and who are unwilling to reduce their intake to below 1600 IU/day during the study period.. 3. Patients receiving vitamin D (ergocalciferol or cholecalciferol) at doses > 12,000 IU/week or 300 µg/week within 8 weeks prior to randomization. 4. Patients with total elemental calcium intake > 1000 mg/day (patients may be included if elemental calcium intake can be discontinued or reduced or switched to non-calcium-containing medication at least 14 days prior to Visit 2). 5. Subjects receiving other vitamin D analogs and/or bone metabolism therapy, including but not limited to: active vitamin D and its analogs (e.g., calcitriol, paricalcitol, doxercalciferol, and alfacalcidol), calcimimetics (e.g., Cinacalcet®), teriparatide, calcitonin, and other drugs that may affect calcium metabolism. (Subjects may be included in this study if these treatments can be discontinued at least 28 days prior to Visit 2). 6. Patients who have used bisphosphonate therapy within 6 months prior to enrollment or who are planning to receive bisphosphonate therapy during the study period 7. Patients who are receiving other bone metabolism therapy (with the exception of bisphosphonates) that may interfere with the study endpoints (patients may be included in this study if these medications can be discontinued at least 28 days prior to Visit 2). 8. Patients using or are expected to use the following drugs during the study: (1) Drugs that affect vitamin D metabolism, including but not limited to ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, voriconazole, phenytoin sodium, phenobarbital, or other anticonvulsants, and other drugs that affect vitamin D metabolism as judged by the Investigator; (2) Drugs that affect vitamin D absorption, including but not limited to docusate sodium, orlistat, cholestyramine, and other drugs that affect vitamin D absorption as judged by the Investigator; (3) Thiazide diuretics (e.g., chlorothiazide, hydrochlorothiazide, bendroflumethiazide, chlortralidone). 9. Presence of a serious disease or medical condition, as judged by the Investigator, in the screening period, such as malignancy, serious gastrointestinal conditions, serious cardiovascular diseases, cardiac dysfunction (e.g., New York Heart Association (NYHA) classification = 3), which, in the opinion of the Investigator, may worsen and/or interfere with participation in this study. 10. Patients with alanine aminotransferase (glutamate pyruvic transaminase, ALT) or glutamic oxaloacetic transaminase (aspartate aminotransferase, AST) > 2.5 × ULN, or total bilirubin > 1.5 × ULN; 11. Patients who have a mental disorder that prevents them from communicating normally with the Investigator or who, in the opinion of the Investigator, are unable to complete protocol-specified visit procedures. 12. Subjects with known or suspected hypersensitivity to the active ingredient or excipients of the investigational drug formulation. 13. Patients infected with Hepatitis B (hepatitis B surface antigen [HbsAg] positive or core antibody [HbcAb] positive and HBV DNA = lower limit of detection), Hepatitis C (hepatitis C virus [HCV] antibody positive and HCV RNA positive), and human immunodeficiency virus (HIV). 14. Patients who have participated in other interventional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| plasma iPTH;hyperphosphatemia; | — |
Secondary
| Measure | Time frame |
|---|---|
| serum total 25(OH)D; | — |
Countries
China
Contacts
Public ContactHongli Lin
The First Affiliated Hospital of Dalian Medical University
Outcome results
None listed