An Open Label, Dose Titration Study Of Sevelamer Carbonate Dosed Three Times A Day In Hyperphosphatemic Chronic Kidney Disease (CKD) Patients Not On Dialysis

An Open Label, Dose Titration Study of Sevelamer Carbonate dosed Three Times A Day in the control of phosphorus levels in Hyperphosphatemic Chronic Kidney Disease Patients Not On Dialysis

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000380594

Enrollment

Registered

2006-08-29

Start date

2006-01-01

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

Interventions

This study will test an 8-week treatment course of the investigational drug Sevelamer Carbonate, at doses from 4.8g up to 12g orally daily, in patients with Hyperphosphatemic CKD not on dialysis.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

CKD patients not on dialysis; documented hyperphosphatemia without the use of a phosphate binder or after washout from current phosphate binder; signed informed consent.

Exclusion criteria

Known hypersensitivity to the investigational product or any constituents of the study drug; active bowel obstruction, dysphagia, swallowing disorder or severe gastrointestinal (GI) motility disorders; in the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition; pregnant or breast-feeding; evidence of active malignancy except for basal cell carcinoma of the skin; unable to comply with the requirements of the study.

Outcome results