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Completed

NCT Number: NCT01069692

Placebo Versus SBR759 in Lowering Phosphate in Dialysis Patients

This study will compare placebo to 4 different doses of SBR759 to assess the phosphate lowering efficacy in dialysis patients.

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Key information

Conditions

Hyperphosphatemia Chronic Disease Chronic Kidney Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Phosphorus Metabolism Disorders 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

Primary location

Novartis Investigative Site, Jette, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men or women of at least 18 years of age
  • Stable maintenance of hemodialysis 3 times per week for 3 months or greater
  • Controlled serum phosphate if under phosphate-binder therapy
  • Patient must either be on a stable phosphate binder dose and are willing to stop their phosphate binder therapy at the beginning of the study, or not have received any phosphate binder therapy for at least 4 weeks prior to screening

Exclusion criteria

  • Patients who are on peritoneal dialysis
  • Patients who have a transplant or parathyroidectomy scheduled during the study
  • Clinically significant GI disorder
  • Unstable medical condition other than Chronic Kidney Disease
  • Patient is currently being treated with oral iron
  • History of hemachromatosis, or ferritin > 1000 ng/mL
  • Transferrin saturation > 60%
  • Uncontrolled hyperparathyroidism (iPTH > 84.8 pmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

SBR759A

Drug

SBR759A 6g daily

Primary outcomes

  1. Evaluate the change from baseline in 72-hour serum phosphate levels of 4 different doses of SBR759 versus placebo over 4 weeks of treatment

    Time frame: 6 weeks

Secondary outcomes

  1. Evaluate changes in serum phosphate during a 2 week random treatment withdrawal period of SBR759 after 4 weeks treatment

    Time frame: 6 weeks

  2. Evaluate dose-dependent efficacy of SBR759

    Time frame: 6 weeks

  3. Compare the short-term safety profile and dose-dependent tolerability of SBR759 dosed with meals taken 3 times a day to that of placebo

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A Double-blind, Randomized, Placebo-controlled Multi-center Trial to Compare the Phosphate Lowering Efficacy of Different Doses of SBR759 to Placebo

Acronym: SBR759

Important dates

Study start
2010
Primary completion
2010
First posted
Feb 17, 2010
Registry last updated
Dec 19, 2020

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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