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Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone (REALIZE-K)

Primary Purpose

Hyperkalaemia, Heart Failure With Reduced Ejection Fraction

Status
Recruiting
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Sodium zirconium cyclosilicate
Placebo
Spironolactone
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperkalaemia

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

INCLUSION CRITERIA

  • Adults aged ≥18 years
  • Potassium and estimated glomerular filtration rate (eGFR):
  • Cohort 1: sK+ 5.1-5.9 mEq/L at screening/study enrolment and eGFR ≥30 mL/min/1.73 m2; OR
  • Cohort 2: Normokalaemic (sK+ 3.5-5.0 mEq/L) at screening and 'at risk' of developing HK defined as either:
  • Have a history of HK (sK+ >5.0 mEq/L) within the prior 24 months and eGFR ≥30 mL/min/1.73 m2, or
  • sK+ ≥4.5 mEq/L and eGFR 30 to 60 mL/min/1.73 m2 and/or age >75 years
  • Symptomatic HFrEF (New York Heart Association [NYHA] class II-IV), which has been present for at least 3 months
  • Left ventricular ejection fraction (LVEF) ≤40%
  • Receiving angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi) (stable dose for ≥4 weeks)
  • Not on spironolactone or eplerenone, or on low-dose spironolactone (<25 mg daily).
  • Receiving beta-blocker (stable dose for ≥4 weeks) unless contraindicated.

EXCLUSION CRITERIA Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or severe stenotic valve disease as a primary cause of HF

  • Current inpatient hospitalisation due to HF
  • Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomisation

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Open-label run-in phase

Randomized withdrawal phase (6 months)

Arm Description

Cohort 1 (4 weeks duration): Patients who are hyperkalemic at study entry will begin SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily). Cohort 2 (up to 6 weeks duration): Patients who develop hyperkalemia during the uptitration of spironolactone will receive SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily).

SZC arm and Placebo arm: Patients will continue on the SZC dose they were receiving at the end of the run-in phase. The SZC / Placebo dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily).

Outcomes

Primary Outcome Measures

Occurrence (yes/no) of patients on SZC compared to placebo who, at the EOT, have serum potassium (sK+) within 3.5-5.0 mEq/L are on spironolactone ≥25 mg daily, and did not use rescue therapy for HK at any point during the randomised-withdrawal phase
To evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK)

Secondary Outcome Measures

Occurrence (yes/no) of patients on SZC compared to placebo who at the EOT visit,have sK+ within 3.5-5.0 mEq/L and are on the same dose of spironolactone as randomisation without use of rescue therapy for HK at any point in the randomised-withdrawal phase
To compare the SZC and placebo arms with respect to keeping potassium levels within a normal range (3.5-5.0 mEq/L), keeping same spironolactone dose as used at randomisation, and without having had assistance of rescue therapy for HK
Occurrence (yes/no) of patients on SZC compared to placebo who, at the EOT visit, are on spironolactone ≥25 mg daily. Patients who are lost to follow-up, including due to death, prior to the EOT visit will be treated as non-response.
To compare the SZC and placebo arms with respect to spironolactone dose.
Time to first HK episode for patients on SZC compared to placebo during the randomised withdrawal phase, with HK defined as sK+ >5.0 mEq/L.
To evaluate the efficacy of SZC as compared to placebo in keeping potassium levels ≤5.0 mEq/L.
Time to first instance of decrease or discontinuation of spironolactone dose due to HK for patients on SZC compared to placebo during the randomised-withdrawal phase.
To compare the SZC and placebo arms with respect to ability to prevent decreases in spironolactone dose.
Change in KCCQ-CSS at EOT visit from randomisation for patients on SZC compared to placebo.
To compare the SZC and placebo arms with respect to change from randomisation in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)

Full Information

First Posted
December 16, 2020
Last Updated
October 10, 2023
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04676646
Brief Title
Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone
Acronym
REALIZE-K
Official Title
Phase IV, Double-Blind, Placebo-Controlled, Randomized-Withdrawal Trial Evaluating Sodium Zirconium Cyclosilicate (SZC) for the Management of Hyperkalaemia in Patients With Symptomatic Heart Failure With Reduced Ejection Fraction and Receiving Spironolactone
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main objective of this study is to evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK).
Detailed Description
REALIZE-K is a Phase 4, multinational, multicenter, double-blind, placebo-controlled, randomized-withdrawal, parallel-group study that includes the following 3 phases: screening, 4-6 week open-label run-in phase where sodium zirconium cyclosilicate (SZC) and spironolactone will be optimized, followed by a 6-month double-blind, placebo-controlled, randomized withdrawal treatment phase. Patients meeting the following criteria will enter the 4-6 week open-label run-in phase: symptomatic heart failure with reduced ejection fraction (HFrEF); receiving an angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi); receiving no spironolactone or eplerenone, or receiving low-dose spironolactone (<25 mg daily); receiving a beta-blocker unless contraindicated; AND with hyperkalemia (sK+ 5.1-5.9 mEq/L) and an eGFR >/= 30 mL/min/1.73m2, OR normokalemic (sK+ 3.5-5.0 mEq/L) and 'at risk' of developing hyperkalemia (ie, history of hyperkalemia within the past 36 months and eGFR >/= 30 mL/min/1.73m2, or sK+ 4.5-5.0 mEq/L and eGFR 30-60 mL/min/1.73m2 and/or age >75 years). Patients who are normokalemic on SZC and receiving spironolactone >/= 25 mg daily at the end of the open-label run-in phase will enter the 6-month double-blind, placebo-controlled, randomized withdrawal treatment phase. Eligible patients will be randomized 1:1, stratified by run-in phase sK+ cohort.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperkalaemia, Heart Failure With Reduced Ejection Fraction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
REALIZE-K is a Phase 4, multinational, multicenter, double-blind, placebo-controlled, randomized-withdrawal, parallel-group study.
Masking
ParticipantInvestigator
Masking Description
All participants entering the double-blind, randomised treatment period will be centrally assigned to randomised study intervention using an Interactive Response Technology/Randomisation and Trial Supply Management (IRT/RTSM). Randomisation will be stratified by the sK+ cohort determined by central laboratory at the start of the open-label phase (Day 1). Before the study is initiated, the telephone number and call-in directions for the IRT and/or the log in information and directions for the RTSM will be provided to each site. The IRT/RTSM will provide to the investigator(s) or pharmacists the kit identification number to be allocated to the participant at the dispensing visit. Routines for this will be described in the IRT/RTSM user manual that will be provided to each centre. The randomisation code should not be broken except in medical emergencies when the appropriate management of the participant requires knowledge of the treatment randomisation.
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-label run-in phase
Arm Type
Experimental
Arm Description
Cohort 1 (4 weeks duration): Patients who are hyperkalemic at study entry will begin SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily). Cohort 2 (up to 6 weeks duration): Patients who develop hyperkalemia during the uptitration of spironolactone will receive SZC 10 g TID for up to 48 hours followed by SZC 10 g once daily to achieve and maintain normokalemia. The SZC dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily).
Arm Title
Randomized withdrawal phase (6 months)
Arm Type
Experimental
Arm Description
SZC arm and Placebo arm: Patients will continue on the SZC dose they were receiving at the end of the run-in phase. The SZC / Placebo dose will be adjusted as needed to maintain normokalemia (dose range = 5 g every other day, to 5-15 g once daily).
Intervention Type
Drug
Intervention Name(s)
Sodium zirconium cyclosilicate
Other Intervention Name(s)
SZC
Intervention Description
Investigational medicinal product
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo comparator
Intervention Type
Other
Intervention Name(s)
Spironolactone
Intervention Description
Background intervention. During the run-in phase, spironolactone will be initiated/uptitrated up to a maximum of 50 mg per day. During the randomized withdrawal phase the spironolactone dose at the end of the run-in phase will be maintained.
Primary Outcome Measure Information:
Title
Occurrence (yes/no) of patients on SZC compared to placebo who, at the EOT, have serum potassium (sK+) within 3.5-5.0 mEq/L are on spironolactone ≥25 mg daily, and did not use rescue therapy for HK at any point during the randomised-withdrawal phase
Description
To evaluate the efficacy of SZC as compared with placebo in keeping potassium levels within the normal range (3.5-5.0 mEq/L) while on spironolactone ≥25 mg daily without assistance of rescue therapy for hyperkalaemia (HK)
Time Frame
From randomization to the end of treatment (EOT) visit (approximately 6 months post-randomisation)
Secondary Outcome Measure Information:
Title
Occurrence (yes/no) of patients on SZC compared to placebo who at the EOT visit,have sK+ within 3.5-5.0 mEq/L and are on the same dose of spironolactone as randomisation without use of rescue therapy for HK at any point in the randomised-withdrawal phase
Description
To compare the SZC and placebo arms with respect to keeping potassium levels within a normal range (3.5-5.0 mEq/L), keeping same spironolactone dose as used at randomisation, and without having had assistance of rescue therapy for HK
Time Frame
From randomization to the end of treatment (EOT) visit (approximately 6 months post-randomisation)
Title
Occurrence (yes/no) of patients on SZC compared to placebo who, at the EOT visit, are on spironolactone ≥25 mg daily. Patients who are lost to follow-up, including due to death, prior to the EOT visit will be treated as non-response.
Description
To compare the SZC and placebo arms with respect to spironolactone dose.
Time Frame
From randomization to the end of treatment (EOT) visit (approximately 6 months post-randomisation)
Title
Time to first HK episode for patients on SZC compared to placebo during the randomised withdrawal phase, with HK defined as sK+ >5.0 mEq/L.
Description
To evaluate the efficacy of SZC as compared to placebo in keeping potassium levels ≤5.0 mEq/L.
Time Frame
From randomization to the end of treatment (EOT) visit (approximately 6 months post-randomisation)
Title
Time to first instance of decrease or discontinuation of spironolactone dose due to HK for patients on SZC compared to placebo during the randomised-withdrawal phase.
Description
To compare the SZC and placebo arms with respect to ability to prevent decreases in spironolactone dose.
Time Frame
From randomization to the end of treatment (EOT) visit (approximately 6 months post-randomisation)
Title
Change in KCCQ-CSS at EOT visit from randomisation for patients on SZC compared to placebo.
Description
To compare the SZC and placebo arms with respect to change from randomisation in Kansas City Cardiomyopathy Questionnaire Clinical Summary Score (KCCQ-CSS)
Time Frame
From randomization to the end of treatment (EOT) visit (approximately 6 months post-randomisation)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
INCLUSION CRITERIA Adults aged ≥18 years Potassium and estimated glomerular filtration rate (eGFR): Cohort 1: sK+ 5.1-5.9 mEq/L at screening/study enrolment and eGFR ≥30 mL/min/1.73 m2; OR Cohort 2: Normokalaemic (sK+ 3.5-5.0 mEq/L) at screening and 'at risk' of developing HK defined as any of the following: Have a history of HK (sK+ >5.0 mEq/L) within the prior 36 months and eGFR ≥30 mL/min/1.73 m2; or sK+ 4.5-5.0 mEq/L and eGFR 30 to 60 mL/min/1.73 m2; or sK+ 4.5-5.0 mEq/L, and age >75 years Symptomatic HFrEF (New York Heart Association [NYHA] class II-IV), which has been present for at least 3 months Left ventricular ejection fraction (LVEF) ≤40% Receiving angiotensin-converting enzyme inhibitor (ACEi), angiotensin II receptor blocker (ARB), or angiotensin receptor-Neprilysin inhibitor (ARNi) Not on or on low-dose spironolactone or eplerenone (<25 mg daily) Receiving beta-blocker unless contraindicated EXCLUSION CRITERIA Heart failure due to restrictive cardiomyopathy, active myocarditis, constrictive pericarditis, hypertrophic (obstructive) cardiomyopathy, or severe stenotic valve disease as a primary cause of HF Current inpatient hospitalisation with unstable HF, defined as any of the following: Systolic blood pressure <95 mmHg during the 6 hours prior to screening. Intravenous diuretic therapy during the 12 hours prior to screening. Use of intravenous inotropic drugs during the 24 hours prior to screening. Received mechanical circulatory support during the 48 hours prior to screening Previous cardiac transplantation or implantation of a ventricular assistance device (VAD) or similar device, or transplantation or implantation expected after randomisation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Fairhope
State/Province
Alabama
ZIP/Postal Code
36532
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Peachtree Corners
State/Province
Georgia
ZIP/Postal Code
30092
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60202
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429-2196
Country
United States
Individual Site Status
Terminated
Facility Name
Research Site
City
Hazel Crest
State/Province
Illinois
ZIP/Postal Code
60429-2196
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
McKinney
State/Province
Texas
ZIP/Postal Code
75071
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aracaju
ZIP/Postal Code
49015-380
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30110-017
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belo Horizonte
ZIP/Postal Code
30150-240
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Bragança Paulista
ZIP/Postal Code
12916-542
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
70390-700
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brasília
ZIP/Postal Code
71615-907
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Campina Grande do Sul
ZIP/Postal Code
83430-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Canoas
ZIP/Postal Code
92425-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Joinville
ZIP/Postal Code
89201-490
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Olinda
ZIP/Postal Code
53030-010
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Passo Fundo
ZIP/Postal Code
99010-080
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90020-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035-903
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ribeirao Preto
ZIP/Postal Code
14026-020
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22271-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salvador
ZIP/Postal Code
41810-011
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santa Cruz Do Sul
ZIP/Postal Code
96835-090
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01321-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05652-9000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Serraria
ZIP/Postal Code
57046-295
Country
Brazil
Individual Site Status
Withdrawn
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
04556-100
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Votuporanga
ZIP/Postal Code
15500-003
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brampton
State/Province
Ontario
ZIP/Postal Code
L6Z 4N5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R 6V6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2N 1B2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1S 4N6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1M8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Whitby
State/Province
Ontario
ZIP/Postal Code
L1N 5T2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1C8
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Terrebonne
State/Province
Quebec
ZIP/Postal Code
J6V 2H2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1R 2J6
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Brandys nad Labem
ZIP/Postal Code
250 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brno
ZIP/Postal Code
602 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brno
ZIP/Postal Code
639 00
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Broumov
ZIP/Postal Code
55001
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Frýdek-Místek
ZIP/Postal Code
738 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hradec Kralove
ZIP/Postal Code
500 02
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaromer
ZIP/Postal Code
55101
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Louny
ZIP/Postal Code
440 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
77900
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Uherske Hradiste
ZIP/Postal Code
68601
Country
Czechia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cegléd
ZIP/Postal Code
2700
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kecskemét
ZIP/Postal Code
6000
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Zalaegerszeg
ZIP/Postal Code
8900
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Gdynia
ZIP/Postal Code
81-157
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
31-121
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
90-553
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lodz
ZIP/Postal Code
91-002
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lódz
ZIP/Postal Code
93-513
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-192
Country
Poland
Individual Site Status
Suspended
Facility Name
Research Site
City
Puławy
ZIP/Postal Code
24-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sopot
ZIP/Postal Code
81-717
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Warszawa
ZIP/Postal Code
04-404
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
50-084
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Żarów
ZIP/Postal Code
58-130
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
A Coruna
ZIP/Postal Code
15006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Almeria
ZIP/Postal Code
4009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Barcelona
ZIP/Postal Code
8041
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bilbao (Vizcaya)
ZIP/Postal Code
48013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ciudad Real
ZIP/Postal Code
13005
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Denia
ZIP/Postal Code
03700
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Granada
ZIP/Postal Code
18016
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Huelva
ZIP/Postal Code
21005
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaen
ZIP/Postal Code
23007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lleida
ZIP/Postal Code
25198
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Palma de Mallorca
ZIP/Postal Code
07010
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Palma de Mallorca
ZIP/Postal Code
07198
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sabadell
ZIP/Postal Code
08208
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Santiago de Compostela
ZIP/Postal Code
15706
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Cherkasy
ZIP/Postal Code
18009
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76005
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kharkiv Region
ZIP/Postal Code
61058
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kharkiv
ZIP/Postal Code
61176
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
02660
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03015
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
03151
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Kyiv
ZIP/Postal Code
3680
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Lutsk
ZIP/Postal Code
43024
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Lviv
ZIP/Postal Code
79015
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Odesa
ZIP/Postal Code
65025
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ternopil
ZIP/Postal Code
46001
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Uzhgorod
ZIP/Postal Code
88014
Country
Ukraine
Individual Site Status
Suspended
Facility Name
Research Site
City
Ashington
ZIP/Postal Code
NE63 9JJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bridgend
ZIP/Postal Code
CF31 1RQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bristol
ZIP/Postal Code
BS105NB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dundee
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Suspended
Facility Name
Research Site
City
Leicester
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manchester
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newport
ZIP/Postal Code
NP20 2UB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sheffield
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home

Learn more about this trial

Study to Assess Efficacy and Safety of SZC for the Management of High Potassium in Patients With Symptomatic HFrEF Receiving Spironolactone

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