Cápsulas blandas de Paricalcitol para la Hiperparatiroidismo secundaria en Enfermedad Renal Crónica

Fecha de inicio: 1 de febrero de 2022

Inclusion Criteria: 1. Under care of physician at least 2 months for CKD 2. Not on active Vitamin D and Calcimimetic therapy for at least 4 weeks prior 3. If taking phosphate binders, on a stable regimen at least 4 weeks prior 4. For entry into Pretreatment Phase: iPTH at least 120 pg/mL GFR of 15-60 mL/min and no dialysis expected for at least 6 months 5. For entry into Treatment Phase: Average of 2 consecutive iPTH values of at least 150 pg/mL, taken at least 1 day apart (all values not less than 120 pg/mL) 2 consecutive corrected serum calcium levels between 8.0-10.0 mg/dL 2 consecutive serum phosphorus levels of not more than 5.2 mg/mL Exclusion Criteria: 1. Subjects who had Primary hyperparathyroidism; 2. Subjects with a history of acute renal failure; 3. Subjects with chronic gastrointestinal disease or severe liver disease with clinical symptoms; 4. Subjects with a history of unstable angina, grade III or IV congestive heart failure, and/or clinically meaningful arrhythmia; 5. Subjects with serum albumin \< 30g/L, serum hemaoglobin \< 85g/L, or serum transaminase higher than 2.5 times the upper limit of nomal; 6. Subjects with a history of malignancy; 7. Subjects who plan to undergo surgery during the study period; 8. Subjects with a history active granulomatous diseases; 9. Subject with a history of alcohol abuse and drug abuse; 10. Human immunodeficiency virus antibody (HIV-Ab), hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab) or Treponema pallidum antibody (TP-Ab) are positive; 11. Subjects who are allergic to the test drug and its ingredients or excipients; 12. Subjects who combined with systemic or systemic diseases that are not suitable for clinical trials; 13. Subjects who have participated in clinical trials of other drugs or devices;