Clinical Trial: Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate in Hemodialysis Patients : Landmark Study

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Outcome Study of Lanthanum Carbonate Compared With Calcium Carbonate on Cardiovascular Mortality and Morbidity in Patients With Chronic Kidney Disease on Hemodialysis (CKD5D)

Brief Summary: The purpose of this study is to demonstrate decrease in cardiovascular mortality and morbidity in Japanese hemodialysis patients treated with Lanthanum carbonate compared with those with Calcium carbonate.

Detailed Summary: Elevated serum phosphate and calcium in dialysis patients are independently associated with increased risk of arterial calcification and mortality. Calcium-based phosphate binders can induce hypercalcaemia and are associated with progression of vascular calcification. A recent randomized study demonstrated that sevelamer, a non-calcium-based phosphate binders, reduced mortality in elderly hemodialysis patients compared with calcium-based phosphate binders. Lanthanum carbonate is another efficacious and well-tolerated non-calcium phosphate binder. A post-hoc survival analysis of lanthanum carbonate versus standard therapy suggested a survival benefit of lanthanum carbonate treatment for elderly patients.
Sponsor: Translational Research Informatics Center, Kobe, Hyogo, Japan

Current Primary Outcome: Cardiovascular event free survival time. [ Time Frame: 3 years ]

Cardiovascular event consisting of

  1. death due to cardiovascular diseases including sudden cardiac death (ICD-10 codes R96.0/96.1),
  2. nonfatal myocardial infarction,
  3. nonfatal cerebral stroke including transient ischemic attack, TIA,
  4. unstable angina,
  5. hospitalization for heart failure,
  6. hospitalization for ventricular arrhythmia


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Overall survival [ Time Frame: 3 years ]
  • Secondary hyperparathyroidism free survival [ Time Frame: 3 years ]
  • Hip fracture free survival [ Time Frame: 3 years ]
  • Quality of life questionnaire (KDQOL-SF, v1.3) [ Time Frame: 3 years ]
  • Bone mineral density (DEXA) [ Time Frame: 3 years ]


Original Secondary Outcome: Same as current

Information By: Translational Research Informatics Center, Kobe, Hyogo, Japan

Dates:
Date Received: April 13, 2012
Date Started: December 2011
Date Completion: June 2017
Last Updated: September 27, 2016
Last Verified: September 2016