Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease
2 other identifiers
interventional
30
1 country
1
Brief Summary
Recently it has been documented that vitamin D has important functions in the human body that are unrelated to its primary effects in calcium homeostasis and bone mineralization. In clinical studies, paricalcitol - a low-calcemic vitamin D analogue - has been shown to decrease proteinuria, a marker of disease progression and cardiovascular risk in patients with chronic kidney disease (CKD). The purpose of this study is to investigate the effect of a paricalcitol on renal and cardiovascular variables in patients with moderate to severe CKD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2010
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 2, 2010
CompletedFirst Posted
Study publicly available on registry
June 3, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedJanuary 25, 2012
January 1, 2012
1.4 years
June 2, 2010
January 24, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
plasma renin concentration
6 weeks
Secondary Outcomes (26)
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
- +21 more secondary outcomes
Study Arms (2)
Paricalcitol
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Kidney disease corresponding to eGFR: 15-59 ml/min
- Albuminuria \> 30 mg/l
You may not qualify if:
- Total parathyroidectomy
- Diabetes Mellitus
- Cancer
- Illicit drug or alcohol abuse
- Pregnancy og nursing
- Ongoing NSAID or corticosteroid treatment
- b-hemoglobin \< 6 mmol/l
- p-albumin \< 25 mmol/l
- Clinically significant hypercalcemia
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Medical Research
Holstebro, Holstebro, 7500, Denmark
Related Publications (1)
Larsen T, Mose FH, Bech JN, Pedersen EB. Effect of paricalcitol on renin and albuminuria in non-diabetic stage III-IV chronic kidney disease: a randomized placebo-controlled trial. BMC Nephrol. 2013 Jul 26;14:163. doi: 10.1186/1471-2369-14-163.
PMID: 23889806DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erling B Pedersen, Prof, MSci
Department of Medical Research
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, MSci
Study Record Dates
First Submitted
June 2, 2010
First Posted
June 3, 2010
Study Start
July 1, 2010
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
January 25, 2012
Record last verified: 2012-01