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Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

Primary Purpose

Hyperkalemia

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

Zirconium Cyclosilicate

About this trial

This is an interventional supportive care trial for Hyperkalemia

Eligibility Criteria

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

Inclusion Criteria:

Provision of informed consent prior to any study specific procedures.
Patients aged ≥18. For patients aged <20 years, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
Two consecutive i-STAT potassium values, measured 60-minutes (± 15 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction Phase Study Day 1.
Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5 and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1 hour apart are required). i-STAT potassium measurement should be performed in the morning before breakfast and in the evening before dinner in PD patients on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD), respectively.
Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test within 1 day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 1 year are not considered to be of childbearing potential.

Exclusion Criteria:

Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS.
Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug. Washout of SPS and CPS for 7 days (or longer) prior to the first dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically acceptable by the investigator. Documented informed consent has to be obtained prior to the washout.
Patients with a life expectancy of less than 12 months
Female patients who are pregnant, lactating, or planning to become pregnant
Patients who have an active or history of diabetic ketoacidosis
Known hypersensitivity or previous anaphylaxis to ZS or to components thereof
Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry.
Patients with cardiac arrhythmias that require immediate treatment
Hemodialysis patients (including those who are on both PD and hemodialysis [HD])
Patients who have been on PD less than 6 months or more than 6 months with a history of hypokalemia within 6 months before Correction Phase Day 1
Documented Glomerular Filtration Rate (GFR) < 15 mL/min within 90 days prior to study entry (Non peritoneal dialysis (PD) patients only)
If patients joined ZS study in the past, the patients cannot join this study within the last 30 days of the last study drug administration day.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Sodium Zirconium Cyclosilicate

Arm Description

Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.

Outcomes

Primary Outcome Measures

Number of Patients Who Experienced Adverse Events (AEs) in the MP

The number of patients who experienced any AE, including those which were serious (SAE), had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the MP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.

Secondary Outcome Measures

Percentage of Patients Who Were Normokalemic in the MP

The percentage of patients who were normokalemic at each study visit in the MP is presented. Normokalemia was defined as a serum potassium (S-K) level of ≥ 3.5 and ≤ 5.0 mmol/L. The percentage of patients who were normokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.

Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP

The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented.

Percentage of Patients Who Were Hypokalemic in the MP

The percentage of patients who were hypokalemic at each study visit in the MP is presented. Hypokalemia was defined as a S-K level of < 3.5 mmol/L. The percentage of patients who were hypokalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.

Percentage of Patients Who Were Hyperkalemic in the MP

The percentage of patients who were hyperkalemic at each study visit in the MP is presented. Hyperkalemia was defined as a S-K level of >5.0 mmol/L. The percentage of patients who were hyperkalemic at their last on-treatment visit is also presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days on QOD regimen) after the last ZS dose. End of Study was defined as the last ZS dose + 7 days.

Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP

The mean changes from the CP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.

Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP

The mean changes from the MP baseline in S-K level over specified periods of time in the MP are presented. Baseline for the MP was defined as the measurement taken in the morning of the day of entering the MP (MP Day 1).

Mean Number of Normokalemic Days During the MP

The number of normokalemic days during the MP was calculated assuming the time interval between assessments was normokalemic if both the beginning and end assessments for that time interval displayed normal S-K values. If an intermediate scheduled assessment time point was missing, then the scheduled assessment was regarded as not normokalemic. The mean number of normokalemic days for a patient in the MP is presented.

Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study

The mean change in the S-K level from the last on-treatment MP visit to the End of Study is presented. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.

Change From CP Baseline in S-Aldosterone Levels Over the MP

The mean change from CP baseline to MP Day 166 and MP Day 362 in S-aldosterone levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.

Percentage of Patients With Normal S-Aldosterone Levels Over the MP

The percentage of patients with normal S-aldosterone levels up to Day 362 of the MP is presented. The normal range for S-aldosterone was 0 - 776.72 pmol/L. In addition, the percentage of patients with normal S-aldosterone levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-aldosterone assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose.

Change From CP Baseline in S-Bicarbonate Levels Over the MP

The mean change from CP baseline to timepoints in the MP in S-bicarbonate levels is presented. In addition, the mean change from CP baseline to the last on-treatment value is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.

Percentage of Patients With Normal S-Bicarbonate Levels Over the MP

The percentage of patients with normal S-bicarbonate levels up to the End of Study visit in the MP is presented. The normal range for S-bicarbonate was 17 - 32 mmol/L. In addition, the percentage of patients with normal S-bicarbonate levels at the last on-treatment visit is presented. The CP baseline was defined as the last S-bicarbonate assessment immediately prior to the start of the first dose of ZS during the CP. The last on-treatment value was defined as the last measurement taken within 1 day (2 days if on QOD regimen) after the last ZS dose. The End of Study was 7 days after the last ZS dose.

Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

Patients completed the SF-36 v2 questionnaire on Day 1 of the CP and on Day 362 of the MP. The responses to the items assessing the physical and mental health of the patients determined the PCS and MCS based on a standard algorithm. The PCS and MCS scores ranged from 0 (worst possible health state) to 100 (best possible health state). The mean PCS and MCS are presented for the baseline and post-baseline assessments.

Mean Change From CP Baseline in the Mean S-K Levels in the CP

The mean change from the CP baseline at 24, 48 and 72 hours in the CP is presented. The mean change from baseline to the last on-treatment CP value is also presented. The last on-treatment value was defined as the last measurement taken with 1 day (2 days if on the QOD regimen) after the last ZS dose. Baseline for the CP was defined as the mean of 2 different S-K values, recorded 60 minutes apart (to confirm qualification for study entry) on the CP Day 1.

Percentage of Patients Who Were Normokalemic in the CP

The percentage of patients who were normokalemic at 24, 48 and 72 hours in the CP is presented. Normokalemia was defined as a S-K level of ≥ 3.5 and ≤ 5.0 mmol/L.

Number of Patients Who Experienced AEs in the CP

The number of patients who experienced any AE, including SAEs, those which had an outcome of death, were severe, led to discontinuation of ZS or were causally related to ZS are presented for the CP. AEs of special interest are also presented, including oedema-related AEs, cardiac failure and hypertension.

Full Information

NCT ID

NCT03172702

First Posted

May 22, 2017

Last Updated

April 30, 2020

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT03172702

Brief Title

Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

Official Title

A Phase 3 Multicenter Open-label Maintenance Study to Investigate the Long-term Safety of ZS (Sodium Zirconium Cyclosilicate) in Japanese Subjects With Hyperkalemia

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

September 4, 2017 (Actual)

Primary Completion Date

July 6, 2019 (Actual)

Study Completion Date

July 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

The Open-Label Maintenance Study contains an Correction Phase, in which subjects will be dosed with ZS 10 g three times daily (tid) for 24 to 72 hours, followed by a 12-month long-term Maintenance Phase.

Detailed Description

The study will start with the screening period, and all baseline parameters should be measured/collected up to 1 day prior to administration of first dose of study drug on Correction Phase Day 1. Subjects with 2 consecutive i-STAT potassium values ≥ 5.1 mmol/L will enter the Correction Phase and receive ZS 10 g TID for up to 72 hours, depending on potassium values. Once normokalemia (i-STAT potassium between 3.5 and 5.0 mmol/L, inclusive) is restored (whether after 24, 48 or 72 hours), subjects will be entered into the Maintenance Phase to be dosed with ZS at a starting dose of 5 g QD. Potassium (i-STAT and Central Laboratory) will be measured Days 1, 2, 5, 12, 19 and 26 throughout the first month of study and every 4 weeks thereafter until Day 362 (Visit 23) then patients will be required to complete the EOS visit which is 7±1 days after the last administration of study medication. For patients who do not enter the Maintenance Phase the last visit will be 7±1 day after the last treatment dose in the Correction Phase. The total expected study duration for an individual patient is approximately 53-54 weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hyperkalemia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

150 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Sodium Zirconium Cyclosilicate

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Zirconium Cyclosilicate

Other Intervention Name(s)

Intervention Description

Primary Outcome Measure Information:

Title

Number of Patients Who Experienced Adverse Events (AEs) in the MP

Description

Time Frame

First MP dose up to 1 day (2 days for QOD regimen) after last MP dose.

Secondary Outcome Measure Information:

Title

Percentage of Patients Who Were Normokalemic in the MP

Description

Time Frame

MP Day 1 to End of Study visit (up to 12 months).

Title

Percentage of Patients With Average S-K Levels of ≤5.1 mmol/L and ≤5.5 mmol/L in the MP

Description

The percentage of patients who had an average S-K level of ≤5.1 mmol/L and ≤5.5 mmol/L over the MP up to Day 362 is presented.

Time Frame

MP Day 2 to Day 362.

Title

Percentage of Patients Who Were Hypokalemic in the MP

Description

Time Frame

MP Day 1 to End of Study visit (up to 12 months).

Title

Percentage of Patients Who Were Hyperkalemic in the MP

Description

Time Frame

MP Day 1 to End of Study visit (up to 12 months).

Title

Mean Change From CP Baseline in the Mean S-K Level Over Specified Time Periods in the MP

Description

Time Frame

CP Day 1 to MP Day 362.

Title

Mean Change From MP Baseline in the Mean S-K Level Over Specified Time Periods in the MP

Description

Time Frame

MP Day 1 to Day 362.

Title

Mean Number of Normokalemic Days During the MP

Description

Time Frame

MP Day 1 to Day 362.

Title

Mean Change in S-K Level From Last On-treatment MP Visit to the End of Study

Description

Time Frame

MP Day 1 to End of Study visit (up to 12 months).

Title

Change From CP Baseline in S-Aldosterone Levels Over the MP

Description

Time Frame

CP Day 1, MP Day 166 and MP Day 362.

Title

Percentage of Patients With Normal S-Aldosterone Levels Over the MP

Description

Time Frame

CP Day 1, MP Day 166 and MP Day 362.

Title

Change From CP Baseline in S-Bicarbonate Levels Over the MP

Description

Time Frame

CP Day 1, and MP Day 1 to End of Study visit (up to 12 months).

Title

Percentage of Patients With Normal S-Bicarbonate Levels Over the MP

Description

Time Frame

CP Day 1 and MP Day 1 to End of Study visit (up to 12 months).

Title

Baseline and Post-baseline 36-Item Short Form Health Survey Version 2 (SF-36 v2) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores

Description

Time Frame

CP Day 1 (baseline) and MP Day 362 (post-baseline).

Title

Mean Change From CP Baseline in the Mean S-K Levels in the CP

Description

Time Frame

CP Day 1 to Day 3.

Title

Percentage of Patients Who Were Normokalemic in the CP

Description

The percentage of patients who were normokalemic at 24, 48 and 72 hours in the CP is presented. Normokalemia was defined as a S-K level of ≥ 3.5 and ≤ 5.0 mmol/L.

Time Frame

CP Day 1 to Day 3.

Title

Number of Patients Who Experienced AEs in the CP

Description

Time Frame

Day 1 of CP to last CP dose + 1 day or first MP dose -1 day, earlier.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

130 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Provision of informed consent prior to any study specific procedures. Patients aged ≥18. For patients aged <20 years, a written informed consent should be obtained from the patient and his or her legally acceptable representative. Two consecutive i-STAT potassium values, measured 60-minutes (± 15 minutes) apart, both ≥ 5.1 mmol/L and measured within 1 day before the first dose of ZS on Correction Phase Study Day 1. Patients who are on peritoneal dialysis (PD) can be enrolled if their SK level is ≥5.5 and ≤ 6.5 mmol/L in two consecutive i-STAT potassium evaluation at least 24 hours apart before Day 1 (in each evaluation, two i-STAT potassium measurements at least 1 hour apart are required). i-STAT potassium measurement should be performed in the morning before breakfast and in the evening before dinner in PD patients on continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD), respectively. Women of childbearing potential must be using 2 forms of medically acceptable contraception (at least 1 barrier method) and have a negative pregnancy test within 1 day prior to the first dose of ZS on Correction Phase Study Day 1. Women who are surgically sterile or those who are postmenopausal for at least 1 year are not considered to be of childbearing potential. Exclusion Criteria: Patients treated with lactulose, rifaxan (rifaximin), or other non-absorbed antibiotics for hyperammonemia within 7 days prior to first dose of ZS. Patients treated with resins (such as sevelamer hydrochloride, sodium polystyrene sulfonate [SPS; e.g. Kayexalate®] or calcium polystyrene sulfonate [CPS]), calcium acetate, calcium carbonate, or lanthanum carbonate, within 7 days prior to the first dose of study drug. Washout of SPS and CPS for 7 days (or longer) prior to the first dose of ZS is allowed, if termination of CPS or SPS is judged to be clinically acceptable by the investigator. Documented informed consent has to be obtained prior to the washout. Patients with a life expectancy of less than 12 months Female patients who are pregnant, lactating, or planning to become pregnant Patients who have an active or history of diabetic ketoacidosis Known hypersensitivity or previous anaphylaxis to ZS or to components thereof Treatment with a drug or device within the last 30 days that has not received regulatory approval at the time of study entry. Patients with cardiac arrhythmias that require immediate treatment Hemodialysis patients (including those who are on both PD and hemodialysis [HD]) Patients who have been on PD less than 6 months or more than 6 months with a history of hypokalemia within 6 months before Correction Phase Day 1 Documented Glomerular Filtration Rate (GFR) < 15 mL/min within 90 days prior to study entry (Non peritoneal dialysis (PD) patients only) If patients joined ZS study in the past, the patients cannot join this study within the last 30 days of the last study drug administration day.

Facility Information:

Facility Name

Research Site

City

Akashi-shi

ZIP/Postal Code

674-0063

Country

Japan

Facility Name

Research Site

City

Amagasaki-shi

ZIP/Postal Code

660-8550

Country

Japan

Facility Name

Research Site

City

Chiba-shi

ZIP/Postal Code

260-8712

Country

Japan

Facility Name

Research Site

City

Chiba-shi

ZIP/Postal Code

263-0043

Country

Japan

Facility Name

Research Site

City

Chiyoda-ku

ZIP/Postal Code

101-0047

Country

Japan

Facility Name

Research Site

City

Chuo-ku

ZIP/Postal Code

104-0031

Country

Japan

Facility Name

Research Site

City

Funabashi-shi

ZIP/Postal Code

273-8588

Country

Japan

Facility Name

Research Site

City

Hanyu-shi

ZIP/Postal Code

348-8505

Country

Japan

Facility Name

Research Site

City

Higashiibaraki-gun

ZIP/Postal Code

311-3193

Country

Japan

Facility Name

Research Site

City

Hitachinaka-shi

ZIP/Postal Code

312-0057

Country

Japan

Facility Name

Research Site

City

Ina-shi

ZIP/Postal Code

396-8555

Country

Japan

Facility Name

Research Site

City

Kagoshima-shi

ZIP/Postal Code

892-8580

Country

Japan

Facility Name

Research Site

City

Kahoku-gun

ZIP/Postal Code

920-0293

Country

Japan

Facility Name

Research Site

City

Kamakura-shi

ZIP/Postal Code

247-8533

Country

Japan

Facility Name

Research Site

City

Kasuga-shi

ZIP/Postal Code

816-0864

Country

Japan

Facility Name

Research Site

City

Kasugai-shi

ZIP/Postal Code

486-8510

Country

Japan

Facility Name

Research Site

City

Kasugai-shi

ZIP/Postal Code

487-0016

Country

Japan

Facility Name

Research Site

City

Kawachinagano-shi

ZIP/Postal Code

586-8521

Country

Japan

Facility Name

Research Site

City

Kawasaki-shi

ZIP/Postal Code

216-8511

Country

Japan

Facility Name

Research Site

City

Kitakyushu-shi

ZIP/Postal Code

802-0001

Country

Japan

Facility Name

Research Site

City

Kochi-shi

ZIP/Postal Code

780-0082

Country

Japan

Facility Name

Research Site

City

Koga-shi

ZIP/Postal Code

306-0014

Country

Japan

Facility Name

Research Site

City

Koga-shi

ZIP/Postal Code

306-0041

Country

Japan

Facility Name

Research Site

City

Kumamoto-shi

ZIP/Postal Code

861-8520

Country

Japan

Facility Name

Research Site

City

Matsudo-shi

ZIP/Postal Code

271-0077

Country

Japan

Facility Name

Research Site

City

Matsuyama-shi

ZIP/Postal Code

791-8026

Country

Japan

Facility Name

Research Site

City

Minokamo-shi

ZIP/Postal Code

505-8503

Country

Japan

Facility Name

Research Site

City

Mito-shi

ZIP/Postal Code

311-4153

Country

Japan

Facility Name

Research Site

City

Nagoya-shi

ZIP/Postal Code

457-8511

Country

Japan

Facility Name

Research Site

City

Naka-shi

ZIP/Postal Code

311-0113

Country

Japan

Facility Name

Research Site

City

Omura-shi

ZIP/Postal Code

856-8562

Country

Japan

Facility Name

Research Site

City

Onomichi-shi

ZIP/Postal Code

732-8503

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

530-0001

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

558-8558

Country

Japan

Facility Name

Research Site

City

Osaka-shi

ZIP/Postal Code

559-0012

Country

Japan

Facility Name

Research Site

City

Shimajiri-gun

ZIP/Postal Code

901-0493

Country

Japan

Facility Name

Research Site

City

Shizuoka-shi

ZIP/Postal Code

421-0117

Country

Japan

Facility Name

Research Site

City

Toride-shi

ZIP/Postal Code

302-0022

Country

Japan

Facility Name

Research Site

City

Toshima-ku

ZIP/Postal Code

170-0003

Country

Japan

Facility Name

Research Site

City

Toyohashi-shi

ZIP/Postal Code

441-8570

Country

Japan

Facility Name

Research Site

City

Yao-shi

ZIP/Postal Code

581-0011

Country

Japan

Facility Name

Research Site

City

Yotsukaido-shi

ZIP/Postal Code

284-0027

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

33098526

Citation

Kashihara N, Yamasaki Y, Osonoi T, Harada H, Shibagaki Y, Zhao J, Kim H, Yajima T, Sarai N. A phase 3 multicenter open-label maintenance study to investigate the long-term safety of sodium zirconium cyclosilicate in Japanese subjects with hyperkalemia. Clin Exp Nephrol. 2021 Feb;25(2):140-149. doi: 10.1007/s10157-020-01972-y. Epub 2020 Oct 24.

Results Reference

derived

Links:

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9482C00001&attachmentIdentifier=98c4b9be-0b01-4391-a1da-8544ff12da15&fileName=D9482C00001_CSP_redacted.pdf&versionIdentifier=

Description

D9482C0000 redacted CSP

URL

https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=D9482C00001&attachmentIdentifier=6fcba409-a47f-4c13-a467-f36a2e9f9e10&fileName=D9482C00001_SAP_redacted.pdf&versionIdentifier=

Description

D9482C00001 redacted SAP

Learn more about this trial

Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

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Open-label Safety of Sodium Zirconium Cyclosilicate for up to 12 Months in Japanese Subjects With Hyperkalemia

Hyperkalemia

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial