Lanthanum Versus Calcium Carbonate for Vascular Abnormalities in Patients With CKD and Hyperphosphatemia

Overview

The purpose of this study is to compare the effect of lanthanum carbonate and calcium carbonate on the progression of coronary calcification and vascular endothelial dysfunction.

Full Title of Study: “Lanthanum Carbonate Versus Calcium Carbonate for Vascular Abnormalities in Patients With Chronic Kidney Disease and Hyperphosphatemia”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2023

Interventions

  • Drug: Lanthanum carbonate
  • Drug: Calcium Carbonate

Arms, Groups and Cohorts

  • Active Comparator: Calcium carbonate
    • Start at a dose of 1,500 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 3,000 mg/day.
  • Experimental: Lanthanum carbonate
    • Start at a dose of 750 mg/day, and adjust it to lower serum phosphate concentration <4.5 mg/dL. Maximum dose is 1,500 mg/day. For patients with calcium carbonate at inclusion, calcium carbonate will be replaced with lanthanum carbonate of 750 mg/day.

Clinical Trial Outcome Measures

Primary Measures

  • Coronary artery calcification score
    • Time Frame: 1 year

Secondary Measures

  • Endothelial function
    • Time Frame: 3 months
    • Measured by EndoPAT™ (Itamar Medical Ltd.)
  • Serum bone metabolic markers
    • Time Frame: 3 months
    • Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
  • Serum bone metabolic markers
    • Time Frame: 1 year
    • Bone specific alkaline phosphatase (BAP) and Tartrate-resistant acid phosphatase 5b (TRACP5b)
  • Serum concentrations of calcium, phosphate, intact parathyroid hormone, 25-hydroxyvitamin D, and 1,25-dihydroxyvitamin D over time
    • Time Frame: Up to 1 year
  • Estimated glomerular filtration rate over time
    • Time Frame: Up to 1 year
  • Bone mineral density
    • Time Frame: 1 year
  • Serum osteoprotegerin concentration
    • Time Frame: 3 month
  • Serum osteoprotegerin concentration
    • Time Frame: 1 year
  • Urinary alpha-Klotho to creatinine ratio
    • Time Frame: 3 months
  • Urinary alpha-Klotho to creatinine ratio
    • Time Frame: 1 year
  • Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
    • Time Frame: 3 months
  • Urinary liver-type fatty acid binding protein (L-FABP) to creatinine ratio
    • Time Frame: 1 year
  • End-stage renal disease requiring renal replacement therapy
    • Time Frame: Up to 1 year
  • Cardiovascular event requiring hospitalization
    • Time Frame: Up to 1 year
    • Acute myocardial infarction, angina pectoris, congestive heart failure, stroke, and peripheral vascular disease
  • Death
    • Time Frame: Up to 1 year

Participating in This Clinical Trial

Inclusion Criteria

  • Hyperphosphatemia (For patients without calcium carbonate, ≥4.5 mg/dL) (For patients with calcium carbonate, ≥4.0 mg/dL) – With written informed consent Exclusion Criteria:

  • History of cardiac surgery – With coronary artery stent – Polycystic kidney disease – Hypothyroidism – On treatment with lanthanum carbonate – History of admission within 3 months – History of ileus – Severe liver dysfunction – Severe gastrointestinal dysfunction – Allergy to lanthanum carbonate or calcium carbonate – Pregnant or breastfeeding women – Judged as ineligible by the investigator

Gender Eligibility: All

Minimum Age: 20 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Osaka University
  • Collaborator
    • Bayer
  • Provider of Information About this Clinical Study
    • Principal Investigator: Takayuki Hamano, Endowed chair – Osaka University
  • Overall Official(s)
    • Takayuki Hamano, MD, PhD, Study Chair, Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.