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

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00151918
Collaborator
(none)
48
Enrollment
7.5
Actual Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Lanthanum carbonate
 Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Multi-Centre, Open Label, Randomized, Parallel Group Pilot Study to Assess the Efficacy and Safety of Lanthanum Carbonate and Sevelamer Hydrochloride in Patients Receiving Haemodialysis for End Stage Renal Disease
Actual Study Start Date :
Jan 7, 2005
Actual Primary Completion Date :
Aug 22, 2005
Actual Study Completion Date :
Aug 22, 2005

Outcome Measures

Primary Outcome Measures

  1. Mean pre-dialysis serum phosphate level [The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)]

Secondary Outcome Measures

  1. Mean pre-dialysis serum calcium product [The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)]

  2. Mean pre-dialysis calcium-phosphate product [The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)]

  3. Average daily pill burden [Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.]

  4. Treatment emergent adverse events [Throughout the study period of approximately 7.5 months.]

    Treatment-emergent adverse events (TEAEs) were defined as AEs that had an onset date and time on or after the date and time of the first dose of study medication.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Shire

Investigators

  • Study Director: Study Director, Takeda

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shire
ClinicalTrials.gov Identifier:
NCT00151918
Other Study ID Numbers:
  • SPD405-310
  • 2004-001608-11
First Posted:
Sep 9, 2005
Last Update Posted:
Jul 6, 2021
Last Verified:
Jul 1, 2021
Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency

Study Results

No Results Posted as of Jul 6, 2021