A Clinical Study to Evaluate the Safety, Tolerability and Activity of a New Phosphate Binder (SBR759) in Patients With Chronic Kidney Disease on Hemodialysis

Novartis

Status and phase: Completed; Phase 2; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Drug: SBR759

Study type: Interventional

Funder types: Industry

Identifiers

NCT00750295

CSBR759A2101

Details and patient eligibility

About

The primary objective of this study is to assess the safety, tolerability and activity of escalating multiple doses of SBR759 in patients with chronic kidney disease on hemodialysis.

Enrollment: 60 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients must be treated with maintenance hemodialysis and prescribed a phosphate binder.
• A controlled serum phosphorus.
• Constant dose of concomitant medications.
• Women of child bearing potential must be practicing an acceptable form of birth control (i.e. double barrier method - intrauterine device plus condom, spermicidal gel plus condom). All female patients must have a negative pregnancy test at screening in order to be eligible to participate in the study.

Exclusion criteria

• Patient has been hospitalized within 30 days prior to screening or has a surgery scheduled during the study.
• Patient has an unstable medical condition, an active infection, active malignancy (except for basal cell carcinoma of the skin), a history of major GI tract surgery, or a history of hemochromatosis.
• Patient is receiving or has received an investigational drug (or is currently using an investigational device) within 30 days prior to screening.

Other protocol-defined inclusion/exclusion criteria may apply.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 7 patient groups

1

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

2

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

3

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

4

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

5

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

6

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

7

Experimental group

Treatment:

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759

Drug: SBR759