Secondary hyperparathyroidism in Stage 3 or Stage 4 Chronic Kidney Disease MedDRA version: 9.1 Level: LLT Classification code 10020708 Term: Hyperparathyroidism secondary
Conditions
Interventions
Product Name: doxercalciferol capsules
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: doxercalciferol
CAS Number: 54573-75-0
Concentration unit: µg microgram(s)
Concentration type: equal
Sponsors
Genzyme Europe BV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, aged 18 years or older. 2. CKD Stage 3 or 4, defined as glomerular filtration rate (GFR) from the abbreviated Modification of Diet in Renal Disease (MDRD) equation between 30 and 59 mL/min/1.73m2 for CKD Stage 3 or between 15 and 29 mL/min/1.73m2 for CKD Stage 4 at the Screening Visit. 3. iPTH > 70 pg/mL (> 7.7 pmol/L) for CKD Stage 3 or > 110 pg/mL (> 12.1 pmol/L) for CKD Stage 4, but =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Intact PTH value > 700 pg/mL (> 77.0 pmol/L) at the Week -1 Visit. 2. Corrected serum calcium > 10.0 mg/dL (> 2.5 mmol/L) at Week –1. 3. Serum phosphorus > 5.0 mg/dL (> 1.61 mmol/L) at Week –1. 4. In the opinion of the Investigator, the patient currently has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, human immunodeficiency virus infection, or any other clinically significant, unstable medical condition. 5. Abnormal liver function as measured by alanine aminotransferase (ALT)/aspartate aminotransferase (AST) greater than three times the upper limit of normal at the Screening Visit. 6. Deemed by the Investigator to have rapidly deteriorating renal function. 7. Spot urine calcium/creatinine ratio > 0.2 at Week –1. 8. Current malabsorption, severe chronic diarrhea, or ileostomy. 9. Any evidence of active malignancy except for basal cell carcinoma of the skin. A history of malignancy is not an exclusion criterion. 10. Allergic reaction to a drug which, in the opinion of the Investigator, suggests an increased potential for hypersensitivity to vitamin D therapy. 11. Active ethanol or drug abuse, excluding tobacco use. 12. Current use of aluminum or magnesium based binders. 13. Pregnant or breast-feeding women. 14. Anticipated dialysis or planned renal transplant less than 12 months from Week 0. 15. Treatment with an investigational drug during 30 days preceding the start of screening. 16. Prior renal transplant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of Hectorol Capsules during 52 weeks of treatment in patients with Stage 3 or Stage 4 CKD;Secondary Objective: To evaluate the efficacy of Hectorol Capsules during 52 weeks of treatment in patients with Stage 3 or Stage 4 CKD;Primary end point(s): Safety endpoints include the following: • Incidence of AEs and SAEs. • Changes in physical examination findings, vital signs, or laboratory evaluations. The efficacy endpoint will be the proportion of patients meeting the iPTH target range (defined as iPTH = 70 pg/mL (= 7.7 pmol/L) for Stage 3 patients and iPTH = 110 pg/mL (= 12.1 pmol/L) for Stage 4 patients) at each timepoint during the Treatment Period. | — |
Countries
Germany, Netherlands
Outcome results
None listed