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NCT Number: NCT01748396

Effect of Phosphate Binders on FGF-23 With Concurrent Calcitriol

Chronic kidney disease (CKD) is an established risk factor for cardiovascular morbidity and mortality, as shown by common manifestations of left ventricular hypertrophy (LVH) and arterial calcifications in CKD patients. Fibroblast growth factor-23(FGF-23) is a recently identified phosphaturic hormone that has been reported to be associated with the development of secondary hyperparathyroidism, cardiovascular morbidity, mortality, CKD progression.

While vitamin D is the mainstay therapy in CKD mineral bone disease (CKD-MBD), increased FGF-23 levels have been reported with vitamin D administration. The purpose of this study was to investigate the effect of calcium carbonate when used in conjunction with calcitriol on FGF-23.

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Key information

Conditions

Chronic Kidney Disease Stage 3 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 Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults of 18~70 years of age
  • CKD stage 3 patients (GFR: 30-60ml/min/1.73m2)
  • Patients who've given consent to the trial

Exclusion criteria

  • Known allergy to Vitamin D or calcium carbonate
  • Administration of vitamin D analogue or phosphate binders 3 months prior to study entry
  • History of hypercalcemia (corrected serum calcium > 10.5 mg/dL) or hypophosphatemia (serum phosphate < 2.5 mg/dL) 3 months prior to study entry
  • Patients with bone pathologies or diseases requiring vitamin D therapy that is unrelated to CKD-MBD
  • Administration of concurrent medication , diseases, or history of surgeries that may affect bone-mineral metabolism or alter bone status
  • Patients diagnosed with rapidly progressive glomerulonephritis(RPGN) or those in need of renal replacement therapy
  • Patients with obstructive bowel diseases, or severe gastrointestinal diseases
  • Patients with less than 2 years of life expectancy(ex. Malignancy diseases)

Treatment and study plan

calcitriol

Drug

Calcium Carbonate

Drug

Primary outcomes

  1. Percent changes in FGF-23

    Time frame: 8 weeks after administration

    Comparison of percent changes in FGF-23 from baseline

Secondary outcomes

  1. Percent changes in Ca

    Time frame: 8 weeks after administration

    Comparison of percent change in Ca from baseline

  2. Percent changes in P

    Time frame: 8 weeks after administration

    Comparison of percent change in P from baseline

  3. Percent changes in iPTH

    Time frame: 8 weeks after administration

    Comparison of percent change in intact parathyroid hormone from baseline

  4. Percent changes in 25(OH)D

    Time frame: 8 weeks after administration

    Comparison of percent change in 25(OH)D from baseline

  5. Percent changes in 1,25(OH)2D

    Time frame: 8 weeks after administration

    Comparison of percent change in 1,25(OH)2D from baseline

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Effect of Phosphate Binders on FGF-23 During Calcitriol Administration in CKD Stage 3 Patients

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 12, 2012
Registry last updated
Feb 18, 2013

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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