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Clinical Trial Details

Trial ID: L0227
Source ID: NCT01136564
Associated Drug: Zemplar
Title: Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Chronic Kidney Disease
Interventions: DRUG: Zemplar|DRUG: Placebo
Outcome Measures: Primary: plasma renin concentration, 6 weeks | Secondary: Urinary albumin excretion, 6 weeks|GFR, 6 weeks|Fractional excretion of sodium, 6 weeks|Urinary excretion of aquaporin-2, 6 weeks|Urinary excretion of ENaC-beta, 6 weeks|Urinary excretion of NCC, 6 weeks|Plasma concentration of aldosterone, 6 weeks|Plasma concentration of angiotensin-II, 6 weeks|Plasma concentration of ADH, 6 weeks|Plasma concentration of atrial natriuretic peptide, 6 weeks|Plasma concentration of brain natriuretic peptide, 6 weeks|Plasma concentration of endothelin, 6 weeks|24-hr ambulatory blood pressure, 6 weeks|Central blood pressure, 6 weeks|Pulse wave velocity, 6 weeks|augmentation index, 6 weeks|Plasma concentration of ionized calcium, 6 weeks|Plasma concentration of phosphate, 6 weeks|Plasma concentration of alkaline phosphatase, 6 weeks|Plasma concentration of Parathyroid hormon, 6 weeks|Plasma concentration of 25-hydroxy-vitamin D, 6 weeks|Plasma concentration of ultrasensitive CRP, 6 weeks|Plasma concentration of TNF-alpha, 6 weeks|Plasma concentration of TGF-beta, 6 weeks|Urinary excretion of calcium, 6 weeks|Plasma concentration of ADMA, 6 weeks
Sponsor/Collaborators: Sponsor: Erling Bjerregaard Pedersen
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 30
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2010-07
Completion Date: 2011-12
Results First Posted:
Last Update Posted: 2012-01-25
Locations: Department of Medical Research, Holstebro, 7500, Denmark
URL: https://clinicaltrials.gov/show/NCT01136564