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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00151918

Enrollment

Registered

2005-09-09

Start date

2005-01-07

Completion date

2005-08-22

Last updated

2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Failure, Chronic

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

Interventions

DRUGLanthanum carbonate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Mean pre-dialysis serum phosphate level	The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

Secondary

Measure	Time frame	Description
Average daily pill burden	Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.	—
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.
Mean pre-dialysis serum calcium product	The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)	—
Mean pre-dialysis calcium-phosphate product	The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)	—

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026