The effect of paricalcitol versus placebo on plasma NT-proBNP in patients with type 1 diabetes mellitus and diabetic nephropathy - DiaZemp

Phase 1

• Conditions: Diabetes mellitus type 1 and diabetic nephropathy; MedDRA version: 14.0Level: LLTClassification code 10012638Term: Diabetes with renal manifestationsSystem Organ Class: 10038359 - Renal and urinary disorders

• Registration Number: EUCTR2009-011255-44-DK
• Lead Sponsor: Steno Diabetes Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-06-22
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

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

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 <15ml/min), dialysis, kidney transplantation
7. Liver disease with serum alanine aminotransferase (ALT) increased to more than three times the normal value (analysed at visit 0 and with possibility of re-analysis within a week, the last analysed value being conclusive)
8. Alcohol/drug abuse
9. Hypercalcemia defined as serum ionized calcium >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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:<br>•Vascular calcification and arterial stiffness<br>•Inflammation<br>•endothelial dysfunction <br>•Urinary Albumin Excretion Rate (UAER)<br>;Primary end point(s): Difference in change in plasma NT-proBNP when treated with capsule Zemplar® and capsule placebo