Hyperphosphatemia in patients with end-stage renal disease on hemodialysis. MedDRA version: 16.1 Level: LLT Classification code 10020712 Term: Hyperphosphatemia System Organ Class: 100000004861
Conditions
Interventions
Product Name: AZD1722 tablet 1 mg
Product Code: AZD1722
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: tenapanor (INN Modified: tenapanor dihydrochloride)
CAS Number: 1234365-97-9
Curren
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
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 (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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 150 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 150
Exclusion criteria
Exclusion criteria: 1. Severe hyperphosphatemia defined as >10 mg/dL (3.23 mmol/L) on Phosphate-binders repeatedly during clinical routine monitoring for the 3 preceding months before screening visit 2. Serum parathyroid hormone >1200 pg/mL 3. Significant metabolic acidosis defined as serum bicarbonate <18 mmol/L at last visit prior to randomization, analyzed at the central lab used in the study. 4. Clinical signs of hypovolemia at randomization as judged by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Change in serum phosphate levels from the end of wash out (pre randomization value) to end of treatment.;Secondary Objective: 1. To characterize the dose response relationship of AZD1722 on serum phosphate levels 2. To compare the effect of AZD1722 versus pre wash out phosphate-lowering treatment, by comparing serum phosphate levels during AZD1722 treatment to pre wash out levels 3. To compare the effect of AZD1722 versus placebo on the number of patients reaching serum phosphate goal levels defined as < 5.5 mg/dl (1.78 mmol/L) during 4 weeks of treatment 4. To compare the effect of AZD1722 versus placebo on the change in serum calcium x phosphate product from end of wash out (pre randomization value) to end of treatment 5. To evaluate the safety and tolerability of AZD1722 as assessed by adverse event recording, vital signs, 12-lead electrocardiogram, physical examination, and safety laboratory monitoring ;Primary end point(s): 1. Change in serum phosphate levels;Timepoint(s) of evaluation of this end point: 1. End of wash-out (pre randomization value) to end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Dose response relationship 2. Change from pre wash-out in S-phosphate levels 3. The number of patients reaching S-phosphate goal 4. Change from baseline in calcium x phosphate product 5. Safety and tolerability of AZD1722 ;Timepoint(s) of evaluation of this end point: 1. End of wash-out (pre randomization value) to end of treatment 2. Pre wash-out to end of treatment 3. End of wash-out (pre randomization value) to end of treatment 4. End of wash-out (pre randomization value) to end of treatment 5. End of wash-out (pre randomization value) to end of treatment | — |
Countries
Poland, Slovakia, United Kingdom, United States
Contacts
Public ContactInformation Centre
AstraZeneca
Outcome results
None listed