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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Zemplar
Placebo
Sponsored by
Erling Bjerregaard Pedersen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring paricalcitol, vitamin d, kidney disease, renin, proteinuria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Medical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Paricalcitol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

plasma renin concentration

Secondary Outcome Measures

Urinary albumin excretion
GFR
Fractional excretion of sodium
Urinary excretion of aquaporin-2
Urinary excretion of ENaC-beta
Urinary excretion of NCC
Plasma concentration of aldosterone
Plasma concentration of angiotensin-II
Plasma concentration of ADH
Plasma concentration of atrial natriuretic peptide
Plasma concentration of brain natriuretic peptide
Plasma concentration of endothelin
24-hr ambulatory blood pressure
Central blood pressure
Pulse wave velocity
augmentation index
Plasma concentration of ionized calcium
Plasma concentration of phosphate
Plasma concentration of alkaline phosphatase
Plasma concentration of Parathyroid hormon
Plasma concentration of 25-hydroxy-vitamin D
Plasma concentration of ultrasensitive CRP
Plasma concentration of TNF-alpha
Plasma concentration of TGF-beta
Urinary excretion of calcium
Plasma concentration of ADMA

Full Information

First Posted
June 2, 2010
Last Updated
January 24, 2012
Sponsor
Erling Bjerregaard Pedersen
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1. Study Identification

Unique Protocol Identification Number
NCT01136564
Brief Title
Reno- and Vascular Protective Effect of a Vitamin-D-analogue in Moderate to Severe Chronic Kidney Disease
Official Title
Reno- and Vascular Protective Effect of a Low-calcemic Vitamin-D-analogue (Paricalcitol) in Stage III-IV Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erling Bjerregaard Pedersen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
paricalcitol, vitamin d, kidney disease, renin, proteinuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Zemplar
Intervention Description
2 capsules of 1 microgram daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
2 capsules daily
Primary Outcome Measure Information:
Title
plasma renin concentration
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Urinary albumin excretion
Time Frame
6 weeks
Title
GFR
Time Frame
6 weeks
Title
Fractional excretion of sodium
Time Frame
6 weeks
Title
Urinary excretion of aquaporin-2
Time Frame
6 weeks
Title
Urinary excretion of ENaC-beta
Time Frame
6 weeks
Title
Urinary excretion of NCC
Time Frame
6 weeks
Title
Plasma concentration of aldosterone
Time Frame
6 weeks
Title
Plasma concentration of angiotensin-II
Time Frame
6 weeks
Title
Plasma concentration of ADH
Time Frame
6 weeks
Title
Plasma concentration of atrial natriuretic peptide
Time Frame
6 weeks
Title
Plasma concentration of brain natriuretic peptide
Time Frame
6 weeks
Title
Plasma concentration of endothelin
Time Frame
6 weeks
Title
24-hr ambulatory blood pressure
Time Frame
6 weeks
Title
Central blood pressure
Time Frame
6 weeks
Title
Pulse wave velocity
Time Frame
6 weeks
Title
augmentation index
Time Frame
6 weeks
Title
Plasma concentration of ionized calcium
Time Frame
6 weeks
Title
Plasma concentration of phosphate
Time Frame
6 weeks
Title
Plasma concentration of alkaline phosphatase
Time Frame
6 weeks
Title
Plasma concentration of Parathyroid hormon
Time Frame
6 weeks
Title
Plasma concentration of 25-hydroxy-vitamin D
Time Frame
6 weeks
Title
Plasma concentration of ultrasensitive CRP
Time Frame
6 weeks
Title
Plasma concentration of TNF-alpha
Time Frame
6 weeks
Title
Plasma concentration of TGF-beta
Time Frame
6 weeks
Title
Urinary excretion of calcium
Time Frame
6 weeks
Title
Plasma concentration of ADMA
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erling B Pedersen, Prof, MSci
Organizational Affiliation
Department of Medical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Medical Research
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
23889806
Citation
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.
Results Reference
derived

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

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