chronic kidney disease, stage 3 with secondary hyperparathyroidism and vitamin D deficiency MedDRA version: 21.1 Level: HLGT Classification code 10038430 Term: Renal disorders (excl nephropathies) System Organ Class: 10038359 - Renal and urinary disorders MedDRA version: 20.0 Level: PT Classification code 10020708 Term: Hyperparathyroidism secondary System Organ Class: 10014698 - Endocrine disorders
Conditions
Interventions
Trade Name: D-CURA®
Pharmaceutical Form: Oral solution
INN or Proposed INN: CHOLECALCIFEROL
CAS Number: 67-97-0
Current Sponsor code: GPR-II-18-1
Other descriptive name: CHOLECALCIFEROL CONCENTRATE (
Sponsors
LABORATOIRES SMB S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients must satisfy the following criteria before entering the study: 1) Male and female over 18 years old (18 years inclusive); 2) Having a 25(OH)D3 = 20 ng/mL at the screening visit; 3) Having intact iPTH level = 85 pg/mL and =65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria will be excluded from participating in the study: 1) Evidence of any unstable or untreated clinically significant immunological, renal, neoplastic, endocrine, haematological, hepatic, gastrointestinal, neurological or psychiatric abnormalities or medical disease; 2) Acute impairment of renal function, nephritic proteinuria, malignancies and derangement of mineral metabolism of non-renal origin; 3) Currently on dialysis; 4) History of parathyroidectomy or renal transplantation; 5) Serum calcium corrected by albumin > 2.65 mmol/L (corresponding to 10.6 mg/dl) at screening; 6) Serum phosphorus > 6.0 mg/dl; 7) History of intestinal malabsorption or chronic diarrhea; 8) Use of any vitamin D supplementation alone or in association within 4 weeks before the screening visit; 9) Use of any prohibited medication as detailed in the concomitant medication section; 10) UV light solarium use 2 weeks before the screening visit and during the study; 11) History of drug and/or alcohol abuse; 12) Patients with any sensitivity or allergy to any of the products used within this clinical trial; 13) Participation in any other clinical trial within 2 months of the screening visit; 14) Presence of any other condition or illness, which, in the opinion of the investigator, would interfere with optimal participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To estimate the dose-response on iPTH and related markers of vitamin D3 in chronic kidney disease patients (CKD stage 3) with secondary hyperparathyroidism and vitamin D deficiency.;Secondary Objective: Not applicable;Primary end point(s): Mean change from baseline to week 12 in plasma intact Parathyroid Hormone (iPTH).;Timepoint(s) of evaluation of this end point: at baseline and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline to week 4, 8 and 14 in plasma intact Parathyroid Hormone (iPTH). Mean change from baseline to week 4, 8, 12 and 14 in the 25(OH)D3 serum concentration. Mean change from baseline to week 4, 8, 12 and 14 in the 1,25(OH)2D3 serum concentration. Mean change from baseline to week 4, 8, 12 and 14 in the 24,25(OH)2D3 serum concentration. Mean change from baseline to week 4, 8, 12 and 14 in the FGF23 serum concentration. Percentage of patients reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 12. Time to raise the 25(OH)D3 serum concentration up to 30 ng/ml. • Percentage of patients with a reduction of intact Parathyroid Hormone (iPTH) of at least 30% at week 12. • Percentage of patients with a reduction of intact Parathyroid Hormone (iPTH) of at least 20% at week 12. ;Timepoint(s) of evaluation of this end point: at baseline, and week 4, week 8 and week 12 | — |
Countries
Bulgaria
Contacts
Public ContactCLINICAL DEPARTMENT
LABORATOIRES SMB S.A
Outcome results
None listed