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

Kidney Failure, Chronic Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00151918
• Other study ID #: SPD405-310
• Secondary ID: 2004-001608-11
• Status: Completed
• Phase: Phase 3
• Start date: January 7, 2005
• Est. completion date: August 22, 2005

Study information

• Verified date: July 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 22, 2005
• Est. primary completion date: August 22, 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Kidney Failure, Chronic
• Renal Insufficiency

Intervention

Drug:
• Lanthanum carbonate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean pre-dialysis serum phosphate level		The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Secondary	Mean pre-dialysis serum calcium product		The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Secondary	Mean pre-dialysis calcium-phosphate product		The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)
Secondary	Average daily pill burden		Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.
Secondary	Treatment emergent adverse events	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.	Throughout the study period of approximately 7.5 months.