Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease

Chronic Kidney Disease Clinical Trial

Official title:

Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01136564
• Other study ID #: EBP-TL-2010
• Secondary ID: 2009-017619-14
• Status: Completed
• Phase: Phase 2
• First received: June 2, 2010
• Last updated: January 24, 2012
• Start date: July 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: Regional Hospital Holstebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection AgencyDenmark: Danish Medicines AgencyDenmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Kidney disease corresponding to eGFR: 15-59 ml/min

• Albuminuria > 30 mg/l

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Zemplar
2 capsules of 1 microgram daily
• Placebo
2 capsules daily

Locations

Country	Name	City	State
Denmark	Department of Medical Research	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Erling Bjerregaard Pedersen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma renin concentration		6 weeks	No
Secondary	Urinary albumin excretion		6 weeks	No
Secondary	GFR		6 weeks	No
Secondary	Fractional excretion of sodium		6 weeks	No
Secondary	Urinary excretion of aquaporin-2		6 weeks	No
Secondary	Urinary excretion of ENaC-beta		6 weeks	No
Secondary	Urinary excretion of NCC		6 weeks	No
Secondary	Plasma concentration of aldosterone		6 weeks	No
Secondary	Plasma concentration of angiotensin-II		6 weeks	No
Secondary	Plasma concentration of ADH		6 weeks	No
Secondary	Plasma concentration of atrial natriuretic peptide		6 weeks	No
Secondary	Plasma concentration of brain natriuretic peptide		6 weeks	No
Secondary	Plasma concentration of endothelin		6 weeks	No
Secondary	24-hr ambulatory blood pressure		6 weeks	No
Secondary	Central blood pressure		6 weeks	No
Secondary	Pulse wave velocity		6 weeks	No
Secondary	augmentation index		6 weeks	No
Secondary	Plasma concentration of ionized calcium		6 weeks	Yes
Secondary	Plasma concentration of phosphate		6 weeks	No
Secondary	Plasma concentration of alkaline phosphatase		6 weeks	No
Secondary	Plasma concentration of Parathyroid hormon		6 weeks	No
Secondary	Plasma concentration of 25-hydroxy-vitamin D		6 weeks	No
Secondary	Plasma concentration of ultrasensitive CRP		6 weeks	No
Secondary	Plasma concentration of TNF-alpha		6 weeks	No
Secondary	Plasma concentration of TGF-beta		6 weeks	No
Secondary	Urinary excretion of calcium		6 weeks	No
Secondary	Plasma concentration of ADMA		6 weeks	No