Dose Finding Study to Treat High Phosphate Levels in the Blood.

Ardelyx

Status and phase: Completed; Phase 2

Conditions: Hyperphosphatemia

Treatments: Drug: AZD1722; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02081534

D5613C00001

Details and patient eligibility

About

Randomized. double blind, placebo controlled, parallel arms dose finding study with a 4 weeks treatment period

Full description

The study consists of a screening period of approximately 1 week, a wash out period of up to 3 weeks, where existing phosphate lowering medication is withheld, a 4-week treatment period and a follow-up period of up to 2 weeks, during which patients are put back on their pre washout phosphate lowering medication.

The wash out period will be either 1 week, 2 weeks or 3 weeks depending on the increase in s-phosphate levels.

There are 7 parallel treatment arms in the study with bid and od treatment regimens.

Laboratory efficacy endpoints and safety assessments will be evaluated at various times throughout the study.

The target population of the study is: male or female patients, above18 years of age with End Stage Renal Disease (ESRD) on chronic maintenance hemodialysis (HD) 3 times a week for a minimum of 3 months.

Enrollment: 162 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Females and males aged ≥18 years
2. Chronic maintenance hemodialysis 3 x/week for a at least 3 months
3. Prescribed and taking at least 3 doses of phosphate binder per day
4. Serum phosphate levels should be between 3.5 and 8.0 mg/dL ; 1.13 mmol/L and 2.58 mmol/L (inclusive) at screening
5. Total serum calcium levels 2.0 - 2.6 mmol/L inclusive at screening
6. For randomization in the study, after up to 3 weeks wash out of phosphate binders, patients must have serum phosphate levels of at least 6. 0 mg/dL (1.94 mmol/L) but below 10 mg/dL (3.23 mmol/L) and have had an increase of at least 1.5 mg/dL (0.48 mmol/L) vs pre wash out

Exclusion criteria

1. Severe hyperphosphatemia defined as >10 mg/dL on Phosphate-binders at all time points during clinical routine monitoring for the 3 preceding months before screening visit.

2. Serum parathyroid hormone >1200 pg/mL

3. Significant metabolic acidosis

4. Clinical signs of hypovolemia at randomization

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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162 participants in 7 patient groups, including a placebo group

1 mg bid

Experimental group

Description:

1 mg AZD1722 bid

Treatment:

Drug: AZD1722

3 mg bid

Experimental group

Description:

3 mg AZD1722 bid

Treatment:

Drug: AZD1722

10 mg bid

Experimental group

Description:

10 mg AZD1722 bid

Treatment:

Drug: AZD1722

30 mg bid

Experimental group

Description:

30 mg AZD1722 bid

Treatment:

Drug: AZD1722

3 mg od

Experimental group

Description:

3 mg AZD1722 od

Treatment:

Drug: AZD1722

30 mg od

Experimental group

Description:

30 mg AZD1722 od

Treatment:

Drug: AZD1722

Placebo

Placebo Comparator group

Description:

Placebo (double dummy technique)

Treatment:

Drug: Placebo