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Efficacy and Tolerability of Treatment With Lanthanum Carbonate in Patients With End Stage Renal Disease Receiving Dialysis

This study has been completed.
Sponsor:
Information provided by:
Shire
ClinicalTrials.gov Identifier:
NCT00151931
First received: September 7, 2005
Last updated: August 31, 2011
Last verified: August 2011
  Purpose

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


Condition Intervention Phase
Kidney Failure, Chronic
Drug: Lanthanum carbonate
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Centre, Open-Label Study Assessing the Efficacy and Tolerability of Lanthanum Carbonate in the Reduction of Serum Phosphate Levels in End Stage Renal Disease Patients Receiving Dialysis

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Pre-dialysis serum phosphate levels at 3, 5 and 12 weeks

Secondary Outcome Measures:
  • PTH, serum calcium and calcium-phosphorus product
  • Treatment emergent adverse events

Estimated Enrollment: 456
Study Start Date: May 2004
Study Completion Date: January 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females of childbearing potential agree to take adequate precautions to prevent contraception
  • Patients diagnosed with ESRD must have been receiving a stable dialysis regimen for chronic renal failure for the 2 consecutive months prior to enrollment in the study
  • Patient requires treatment for hyperphosphataemia

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients who continue to require treatment with compounds containing calcium, aluminum or magnesium
  • Patients with clinically significant uncontrolled concurrent illness, a life-threatening malignancy or current multiple myeloma
  • Patients who are HIV+
  • Patients with any significant gastrointestinal surgery or disorders
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00151931

Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Dr. A Hutchison Department of Nephrology, Manchester Royal Infirmary
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00151931     History of Changes
Other Study ID Numbers: SPD405-313
Study First Received: September 7, 2005
Last Updated: August 31, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases

ClinicalTrials.gov processed this record on November 24, 2014