RENO- OG KREDSLØBSPROTEKTIV EFFEKT AF VITAMIN-D-ANALOG (PARICALCITOL) HOS PATIENTER MED MODERAT TIL SVÆR KRONISK NYREINSUFFICIENS

Phase 1

• Conditions: The aim is to measure the effect of paricalcitol given orally in patients with moderate to severe chronic kidney diseases (CKD stage III-IV i.e. eGFR:15-59 ml/min) investigating vasoactive hormones, renal function, calcium metabolism, inflammatory markers, 24-hour ambulatory blood pressure, the nitric oxide system, central blood pressure, pulse wave velocity and augmentation index.; MedDRA version: 12.1Level: LLTClassification code 10064848Term: Chronic kidney disease

• Registration Number: EUCTR2009-017619-14-DK
• Lead Sponsor: Medicinsk Forskningsafsnit, Holstebro

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-02-16
• Last Update Posted: 2 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Age 18-65 years
•Renal disease corresponding to CKD stage 3-4 (eGFR: 15-59 ml/min)
•Both men and women
•Albuminuria > 500 mg/l

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

•Medical history or clinical signs diseases in connective tissue, lungs, liver, endocrine organs
•Former total parathyroidectomy
•Diabetes
•Malignant disease
•Illicit drug use
•Alcohol abuse (according to the recommendations from The Danish National Board of Health)
•Pregnancy or nursing
•Ongoing NSAID or corticosteroid treatment
•Severe anemia (b-hemoglobin <6mmol/l)
•Hypoalbuminemia (p-albumin <25 mmol/l)
•Clinically significant hypercalcemia without calcium or vitamin D treatment.
•Office blood pressure > 170/105 mmHg that despite antihypertensive treatment still is > 170/105 mmHg when using home blood pressure measurements or 24-hour ambulatory blood pressure measurement according to the department’s clinical guidelines.

Study & Design

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