A phase II, randomised, double-blind, and parallel study to estimate the dose-response of vitamin D supplementation in chronic kidney disease patients with secondary hyperparathyroidism and vitamin D deficiency.

ABORATOIRES SMB S.A.0 sites100 target enrollmentJuly 23, 2019

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: chronic kidney disease, stage 3 with secondary hyperparathyroidism and vitamin D deficiency
Sponsor: ABORATOIRES SMB S.A.
Enrollment: 100
Status: Active, not recruiting
Last Updated: 4 years ago

No summary available.

Registry

who.int

Start Date

July 23, 2019

End Date

June 18, 2020

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

ABORATOIRES SMB S.A.

•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).

•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;