“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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000437066

Enrollment

Registered

2010-05-28

Start date

2010-06-25

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief 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

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 week run in period will be considered after the end of the first 6 week study period before any data collection.

Study design

Allocation

Randomised controlled trial

Intervention model

Crossover

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1- Currently receiving haemodialysis treatment for >1 month at The Queen Elizabeth Hospital, The Royal Adelaide Hospital, or affiliated satellite dialysis units (stable regimen during study period). 2- Patient receiving single agent phosphate binders (stable regimen during study period). This include: Calcium Carbonate, Lanthanum Carbonate, Sevelamer hydrochloride, Aluminum Hydroxide.

Exclusion criteria

1- < 18 years of age. 2- Patients unable to give informed consent. 3- Patients enrolled in other investigational drug treatments 4- Patients deemed unable to comply with treatment regime. 5- Home dialysis patients. 6- Peritoneal dialysis patients. 7- Severe indication for acid suppression where withdrawal of acid suppression therapy is deemed unacceptable by the caring physician. (e.g.) a- Major active peptic ulcer diseases b- Major recent gastrointestinal bleeding C- Major Gastro-Oesophageal Reflux Disease (GORD) d- Major gastro-intestinal problems on 7-point Global Overall Symptom (GOS28) scale.

Outcome results