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CompletedNCT01136564Updated Jan 25, 2012

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

A Phase 2 interventional study of Zemplar and Placebo in Chronic Kidney Disease, sponsored by Erling Bjerregaard Pedersen. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-01-25.

Sponsored by Erling Bjerregaard Pedersen · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • paricalcitol
  • vitamin d
  • kidney disease
  • renin
  • proteinuria
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 30 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Erling Bjerregaard Pedersen is the lead sponsor of 16 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Kidney disease corresponding to eGFR: 15-59 ml/min
  • Albuminuria > 30 mg/l

Exclusion criteria

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Paricalcitol

    Drug: Zemplar

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugZemplar

    2 capsules of 1 microgram daily

  • DrugPlacebo

    2 capsules daily

06

What researchers measure

Primary outcomes

  1. plasma renin concentration

    Time frame: 6 weeks

Secondary outcomes

  1. Urinary albumin excretion

    Time frame: 6 weeks

  2. GFR

    Time frame: 6 weeks

  3. Fractional excretion of sodium

    Time frame: 6 weeks

  4. Urinary excretion of aquaporin-2

    Time frame: 6 weeks

  5. Urinary excretion of ENaC-beta

    Time frame: 6 weeks

  6. Urinary excretion of NCC

    Time frame: 6 weeks

  7. Plasma concentration of aldosterone

    Time frame: 6 weeks

  8. Plasma concentration of angiotensin-II

    Time frame: 6 weeks

  9. Plasma concentration of ADH

    Time frame: 6 weeks

  10. Plasma concentration of atrial natriuretic peptide

    Time frame: 6 weeks

  11. Plasma concentration of brain natriuretic peptide

    Time frame: 6 weeks

  12. Plasma concentration of endothelin

    Time frame: 6 weeks

  13. 24-hr ambulatory blood pressure

    Time frame: 6 weeks

  14. Central blood pressure

    Time frame: 6 weeks

  15. Pulse wave velocity

    Time frame: 6 weeks

  16. augmentation index

    Time frame: 6 weeks

  17. Plasma concentration of ionized calcium

    Time frame: 6 weeks

  18. Plasma concentration of phosphate

    Time frame: 6 weeks

  19. Plasma concentration of alkaline phosphatase

    Time frame: 6 weeks

  20. Plasma concentration of Parathyroid hormon

    Time frame: 6 weeks

  21. Plasma concentration of 25-hydroxy-vitamin D

    Time frame: 6 weeks

  22. Plasma concentration of ultrasensitive CRP

    Time frame: 6 weeks

  23. Plasma concentration of TNF-alpha

    Time frame: 6 weeks

  24. Plasma concentration of TGF-beta

    Time frame: 6 weeks

  25. Urinary excretion of calcium

    Time frame: 6 weeks

  26. Plasma concentration of ADMA

    Time frame: 6 weeks

07

Study locations

1 site
  • Department of Medical Research
    Holstebro, 7500, Denmark
08

References and documents

Publications

  • 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. PubMed 23889806 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01136564
Lead sponsor
Erling Bjerregaard Pedersen
Responsible party
Erling Bjerregaard Pedersen (Professor, MD, MSci, Regional Hospital Holstebro) — Sponsor-investigator
First posted
Jun 3, 2010
Start date
Jul 2010
Primary completion
Dec 2011
Completion
Dec 2011
Last update
Jan 25, 2012

Study contacts

Erling B Pedersen, Prof, MSci
principal investigator · Department of Medical Research

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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