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

NCT ID: NCT02237534

Last Updated: 2021-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-30
• Study Completion Date: 2023-09-30

Brief Summary

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.

Conditions

Renal Insufficiency, Chronic; Hyperphosphatemia; Bone Diseases, Metabolic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Calcium Carbonate

Intervention Type: DRUG

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.

Group Type: EXPERIMENTAL

Lanthanum carbonate

Intervention Type: DRUG

Interventions

Lanthanum carbonate

Intervention Type: DRUG

Calcium Carbonate

Intervention Type: DRUG

Other Intervention Names

FOSRENOL®

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: collaborator

Osaka University

OTHER

Sponsor Role: lead

Responsible Party

Takayuki Hamano

Endowed chair

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Takayuki Hamano, MD, PhD

Role: STUDY_CHAIR

Department of Comprehensive Kidney Disease Research, Osaka University Graduate School of Medicine

Locations

Osaka University Hospital

Suita, Osaka, Japan

Countries

Japan

Other Identifiers

CKDR-002

Identifier Type: -

Identifier Source: org_study_id