CompletedPhase 4ACTRN12610000437066

“Effect of acid suppression on the effectiveness of phosphate binders in haemodialysis patients”

The effect of Pantoprazole in comparison to placebo on phosphate control in haemodialysis patients taking phosphate binders.


Sponsor

King Saud University

Enrollment

70 participants

Start Date

Jun 25, 2010

Study Type

Interventional

Conditions

Summary

Hyperphosphatemia (high phosphate concentration in the blood) is common in dialysis patients. Hyperphosphatemia can cause renal bone disease and is also associated with higher mortality. Most dialysis patients are prescribed phosphate binder drugs to bind phosphate in the gut and prevent its absorption. These include Calcium Carbonate (Caltrate (Registered Trademark) or Calsup (Registered Trademark)), Aluminium Hydroxide (Alu-Tab (Registered Trademark)), Lanthanum Carbonate (Fosrenol (Registered Trademark)) and Sevelamer (Renagel (Registered Trademark)). In theory some phosphate binder drugs need the stomach to be acidic to work effectively and bind phosphate. Haemodialysis patients are often prescribed gastric acid suppressant drugs to treat gastric ulcers and gastric reflux disease (heartburn). These drugs include Pantoprazole (Somac (Registered Trademark)), Omeprazole (Losec (Registered Trademark)) and Esomperazole (Nexium (Registered Trademark)). These acid suppressing drugs may reduce stomach acidity and therefore the effectiveness of phosphate binders. This potential drug interaction may worsen hyperphosphatemia The primary purpose of this study to evaluate the effectiveness of phosphate binders in managing hyperphosphataemia when they are co-administered with acid suppressive therapy in haemodialysis patients


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests whether stopping acid-suppressing medications (like those for heartburn) affects how well phosphate-lowering medications work in haemodialysis patients. It is for adults aged 18 and older who are receiving regular haemodialysis at a hospital and taking a single phosphate binder.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Pantoprazole 40 mg once daily Will be administered as oral capsule for two consecutive six-week study periods (2 week run in period + 4 week data collection period) making a total of 12 weeks. Two wee

Pantoprazole 40 mg once daily Will be administered as oral capsule for two consecutive six-week study periods (2 week run in period + 4 week data collection period) making a total of 12 weeks. Two week run in period will be considered after the end of the first 6 week study period before any data collection.


Locations(1)

Australia

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ACTRN12610000437066