Commercial study conducted to determine the most adequate supplementation of vitamin D in patients showing a kidney disease, a vitamin D deficiency and a high level of parathyroid hormone in the blood.
- Conditions
- chronic kidney disease, stage 3 with secondary hyperparathyroidism and vitamin D deficiencyMedDRA version: 21.1Level: HLGTClassification code 10038430Term: Renal disorders (excl nephropathies)System Organ Class: 10038359 - Renal and urinary disordersMedDRA version: 20.0Level: PTClassification code 10020708Term: Hyperparathyroidism secondarySystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2019-000640-10-BG
- Lead Sponsor
- ABORATOIRES SMB S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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 < 500 pg/mL at the screening visit;
4)Having a stable chronic kidney disease stage 3 (estimated eGFR:30-59 mL/min/1.73 m2) at the screening visit;
5)BMI between 18 and 30 kg/m² inclusive;
6)Able to comply with all study procedures;
7)Provide written informed consent to participate in the study, indicated by a personal signature and date on the patient consent form;
8)If the patient is female and of childbearing potential, she must be using an efficient means of birth control (IUD, OCS, spermicide + condom, hormonal patch, implant, vaginal ring), as determined by the investigator and provide a negative blood pregnancy test at the screening visit.
Note: All female patients are considered to be of childbearing potential unless they have undergone hysterectomy or bilateral oophorectomy or have been postmenopausal for at least 12 months (i.e., spontaneous amenorrhea at least 1 year prior to screening).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 75
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): Mean change from baseline to week 4, 8 and 14 in plasma intact Parathyroid Hormone (iPTH).<br>Mean change from baseline to week 4, 8, 12 and 14 in the 25(OH)D3 serum concentration. <br>Mean change from baseline to week 4, 8, 12 and 14 in the 1,25(OH)2D3 serum concentration. <br>Mean change from baseline to week 4, 8, 12 and 14 in the 24,25(OH)2D3 serum concentration. <br>Mean change from baseline to week 4, 8, 12 and 14 in the FGF23 serum concentration. <br>Percentage of patients reaching 25(OH)D3 serum concentrations superior to 30 ng/ml at week 12.<br>Time to raise the 25(OH)D3 serum concentration up to 30 ng/ml.<br>•Percentage of patients with a reduction of intact Parathyroid Hormone (iPTH) of at least 30% at week 12.<br>•Percentage of patients with a reduction of intact Parathyroid Hormone (iPTH) of at least 20% at week 12.<br>;Timepoint(s) of evaluation of this end point: at baseline, and week 4, week 8 and week 12