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Completed

NCT Number: NCT01136564

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

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.

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Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Proteinuria Renal Insufficiency Renal Insufficiency, Chronic Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Medical Research

Holstebro, 7500, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Zemplar

Drug

2 capsules of 1 microgram daily

Placebo

Drug

2 capsules daily

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

Sponsors and collaborators

Lead sponsor

Erling Bjerregaard Pedersen

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 3, 2010
Registry last updated
Jan 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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