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Completed

NCT Number: NCT00151918

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

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lanthanum carbonate

Drug

Primary outcomes

  1. Mean pre-dialysis serum phosphate level

    Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

Secondary outcomes

  1. Mean pre-dialysis serum calcium product

    Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

  2. Mean pre-dialysis calcium-phosphate product

    Time frame: The last 4 weeks of the treatment period (Weeks 5, 6, 7, & 8)

  3. Average daily pill burden

    Time frame: Daily throughout for the 8 week Evaluation for Dose Adjustment Period up to the End of Study/ Withdrawal Visit.

  4. Treatment emergent adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Sep 9, 2005
Registry last updated
Jul 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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