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Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease

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Shire

Status and phase

Completed
Phase 3

Conditions

Kidney Failure, Chronic

Treatments

Drug: Lanthanum carbonate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00151918
2004-001608-11 (EudraCT Number)
SPD405-310

Details and patient eligibility

About

The purpose of this study is to assess phosphate reduction and control in patients with End Stage Renal Disease treated with either lanthanum carbonate or sevelamer hydrochloride

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients receiving haemodialysis for ESRD
  • Patients must have received haemodialysis for chronic renal failure three times per week for at least the previous 2 months

Exclusion criteria

  • Pregnant or lactating women
  • Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
  • Patients who are HIV+
  • Patients with any significant bowel obstruction, active inflammatory bowel disease, GI motility disorders, or a history of major GI surgery within the last 6 months

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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