Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN) (AMETHYST-DN)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Relypsa, Inc.
ClinicalTrials.gov Identifier:
NCT01371747
First received: June 9, 2011
Last updated: November 11, 2015
Last verified: November 2015
Results First Received: November 11, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Chronic Kidney Disease
Hypertension
Hyperkalemia
Intervention: Drug: patiromer

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
324 participants were enrolled in the study; 306 participants were randomized to receive study drug.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Screening serum potassium ≤ 5 mEq/L (milliequivalent) entered Run-in: Cohort 1 stopped ACEI/ARB (angiotensin-converting enzyme inhibitor/angiotensin receptor blockers), started losartan; Cohort 2 started spironolactone; Run-in (Cohorts 1 and 2) or screening (Cohort 3) > 5 mEq/L entered study.

Reporting Groups
  Description
Stratum 1 Participants with baseline serum potassium > 5.0 - 5.5 mEq/L are administered with 8.4 g/day, 16.8 g/day or 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
Stratum 2 Participants with baseline serum potassium > 5.5 - < 6.0 mEq/L are administered 16.8 g/day, 25.2 g/day or 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.

Participant Flow:   Overall Study
    Stratum 1     Stratum 2  
STARTED     222     84  
COMPLETED     157     54  
NOT COMPLETED     65     30  
Adverse Event                 13                 6  
Death                 5                 3  
Abnormal Renal Function                 2                 2  
High Serum Potassium Results                 3                 4  
Low Serum Potassium Results                 3                 4  
Protocol Violation                 1                 0  
Non-Compliance                 10                 1  
Physician Decision                 0                 1  
Withdrawal by Subject                 23                 8  
Other Reasons                 5                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
306 participants were randomized and stratified by baseline serum potassium (2 randomized participants in Stratum 1 did not receive any study drug: 1 participant withdrew consent and 1 participant was randomized in error and was withdrawn from the study); 304 participants were analyzed for safety.

Reporting Groups
  Description
Stratum 1 Participants with baseline serum potassium > 5.0 - 5.5 mEq/L are administered with 8.4 g/day, 16.8 g/day or 25.2 g/day patiromer starting dose, orally, as a divided dose twice a day.
Stratum 2 Participants with baseline serum potassium > 5.5 - < 6.0 mEq/L are administered with 16.8 g/day, 25.2 g/day or 33.6 g/day patiromer starting dose, orally, as a divided dose twice a day.
Total Total of all reporting groups

Baseline Measures
    Stratum 1     Stratum 2     Total  
Number of Participants  
[units: participants]
  220     84     304  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     85     37     122  
>=65 years     135     47     182  
Age  
[units: years]
Median (Full Range)
  68  
  (37 to 80)  
  66.5  
  (39 to 80)  
  67.5  
  (37 to 80)  
Gender  
[units: participants]
     
Female     81     31     112  
Male     139     53     192  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 4 or First Titration ]

2.  Secondary:   Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 8 or First Titration ]

3.  Secondary:   Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group   [ Time Frame: Baseline to Day 3 ]

4.  Secondary:   Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 52 ]

5.  Secondary:   Mean Change in Serum Potassium From End of Treatment to Follow-up Visits Plus 7 Days   [ Time Frame: End of Treatment to Following up Visit Plus 7 Days ]

6.  Secondary:   Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 8 ]

7.  Secondary:   Proportion of Participants Achieving Serum Potassium Levels Within 4.0 to 5.0 mEq/L at Week 8 for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 8 ]

8.  Secondary:   Time to First Serum Potassium Measurement of 4.0 - 5.0 mEq/L During Treatment Initiation Period for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 8 ]

9.  Secondary:   Proportions of Participants Achieving Serum Potassium Levels Within 3.8 to 5.0 mEq/L at Week 52 for Each Individual Starting Dose Group   [ Time Frame: Baseline to Week 52 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Information
Organization: Relypsa, Inc.
phone: 1-844-relypsa
e-mail: medinfo@relypsa.com


Publications:

Responsible Party: Relypsa, Inc.
ClinicalTrials.gov Identifier: NCT01371747     History of Changes
Other Study ID Numbers: RLY5016-205
2011-000165-12 ( EudraCT Number )
Study First Received: June 9, 2011
Results First Received: November 11, 2015
Last Updated: November 11, 2015
Health Authority: Austria: Austrian Federal Office for Safety in Health Care
Croatia: Ministry of Health and Social Welfare of the Republic of Croatia
Georgia: Ministry of Health
Hungary: National Institute of Pharmacy
Serbia: Medicines and Medical Devices Agency of Serbia
Slovenia: Agency for Medicinal products and Medical Devices
Austria: Ethikkommission
Croatia: Ethics Committee
Hungary: Scientific and Medical Research Council Ethics Committee
Serbia: Ethics Committee
Slovenia: Ethics Committee