Diabetes mellitus type 1 and diabetic nephropathy MedDRA version: 14.0 Level: LLT Classification code 10012638 Term: Diabetes with renal manifestations System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Trade Name: Zemplar
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: paricalcitol
CAS Number: 131918-61-1
Other descriptive name: PARICALCITOL
Concentration unit: µg microgram(s)
Concentration
Sponsors
Steno Diabetes Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 18-75 years of age 2. Type 1 diabetes mellitus (WHO criteria) 3. Diabetic nephropathy 4. Chronic kidney disease (eGFR/GFR 15-70ml/min/1.73m2) 5. Parathyroid hormone analysis, s-iPTH> 35pg/ml (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive) 6. Stabile RAAS-blocking and diuretic treatment 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.Diagnosed with other kidney disease than diabetic nephropathy 2. Myocardial infarction within the last three months prior to visit 1 3. Coronary artery revascularization within the last three months prior to visit 1 4. Transitional cerebral ischemia (TCI) or apoplexia within the last three months prior to visit 1 5. Cardiac Failure (NYHA Class III or IV) 6. Kidney Failure (GFR 1.35 mmol /L (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive) 10 Medication with phosphate and/or vitamin D-containing medications, which can not be paused during the study 11. Clinical signs of vitamin D toxicity 12 Pregnant or nursing women 13 Fertile women not using chemical (contraceptive pills, depot injection of depot gestagen, contraceptive implant, vaginal hormonal ring, birth control patch) or mechanical (IUD) contraceptive methods 14 Current disulfiram treatment 15 Allergy to the study drug 16 Patient unable to understand the informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of the impact of three months treatment with capsule Zemplar® (paricalcitol) versus placebo on the primary endpoint: Plasma NT-proBNP in patients with type 1 diabetic nephropathy and chronic kidney disease (eGFR 15-70ml/min) ;Secondary Objective: Evaluation of the intervention on other biomarkers for: • Vascular calcification and arterial stiffness • Inflammation • endothelial dysfunction • Urinary Albumin Excretion Rate (UAER) ;Primary end point(s): Difference in change in plasma NT-proBNP when treated with capsule Zemplar® and capsule placebo | — |
Countries
Denmark
Outcome results
None listed