Efficacy and Safety of Fosrenol in Treating Elevated Serum Phosphate Levels in Adults With End Stage Renal Disease

NCT00160121 | Completed Phase 4

• 1 other identifier: SPD405-401
• Study Type: interventional
• Target: 2,500
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to test how well lanthanum carbonate reduces the pre-dialysis level of serum phosphorus in subjects undergoing dialysis due to end stage renal disease and to determine the patient and physician's satisfaction.

Conditions

Kidney Failure, Chronic

Outcome Measures

Primary Outcomes (5)

• Pre-dialysis serum phosphorus levels at 12 weeks

  Week 12

• Patient satisfaction questionnaire at 12 weeks

  7 question patient satisfaction questionnaire for participants to respond to how strongly they agree or disagree with their experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.

  Week 12

• Physician satisfaction questionnaire at 12 weeks

  6 question physician satisfaction questionnaire for physicians to respond to how strongly they agree or disagree with their patient's experience with the medication received in this clinical trial. Question are based on a 4 point ordinal scale of: Strongly Agree, Agree, Disagree, Strongly Disagree.

  Week 12

• Patient preference questionnaire at 12 weeks

  6 question patient preference questionnaire for participants to respond to whether they preferred the medication they received during this clinical trial or their previous medication.

  Week 12

• Physician preference questionnaire at 12 weeks

  7 question physician preference questionnaire for physicians to respond to whether they preferred the medication administered during this clinical trial or their patient's previous medication.

  Week 12

Interventions

Lanthanum carbonate DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with ESRD who currently require treatment for hyperphosphatemia

You may not qualify if:

• Female patient who is pregnant or lactating
• Patient has used any investigational product within 30 days of screening

Sponsors & Collaborators

• Shire: lead

Related Publications (2)

• Wilson RJ, Keith MS, Preston P, Copley JB. The real-world dose-relativity of sevelamer hydrochloride and lanthanum carbonate monotherapy in patients with end-stage renal disease. Adv Ther. 2013 Dec;30(12):1100-10. doi: 10.1007/s12325-013-0077-5. Epub 2013 Dec 5.

  PMID: 24307220 RESULT

• Keith MS, Wilson RJ, Preston P, Copley JB. Cost-minimization analysis of lanthanum carbonate versus sevelamer hydrochloride in US patients with end-stage renal disease. Clin Ther. 2014 Sep 1;36(9):1276-86. doi: 10.1016/j.clinthera.2014.06.036. Epub 2014 Jul 26.

  PMID: 25069799 RESULT

Related Links

• FDA Recall Information

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

lanthanum carbonate

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: January 10, 2005
• Primary Completion: December 13, 2005
• Study Completion: December 13, 2005
• Last Updated: July 2, 2021

Record last verified: 2021-07