NCT01371747|CompletedPhase 2Results

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

AMETHYST-DN

A Multicenter, Randomized, Open-Label, Dose Ranging Study to Evaluate the Efficacy and Safety of Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy Receiving Angiotensin-converting Enzyme Inhibitor (ACEI) and/or Angiotensin II Receptor Blocker (ARB) Drugs, With or Without Spironolactone

Relypsa, Inc.ClinicalTrials.gov

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2 other identifiers

RLY5016-2052011-000165-12

Study Type

interventional

Target

324

Locations

5 countries

Sites

Timeline

RegisteredJun 2011

StartedJun 2011

CompletionJun 2013

Brief Summary

This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

324

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Jun 2011

Geographic Reach

5 countries

43 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2 years study duration

Study Start

First participant enrolled

June 1, 2011

Completed

8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2011

Completed

4 days until next milestone

First Posted

Study publicly available on registry

June 13, 2011

Completed

1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed

2.5 years until next milestone

Results Posted

Study results publicly available

December 17, 2015

Completed

Last Updated

June 3, 2021

Status Verified

May 1, 2021

Enrollment Period

1.9 years

First QC Date

June 9, 2011

Results QC Date

November 11, 2015

Last Update Submit

May 10, 2021

Conditions

Chronic Kidney Disease Hypertension Hyperkalemia

Keywords

HyperkalemiaChronic Kidney DiseaseTreatment of HyperkalemiaHypertensionDiabetic Nephropathy

Outcome Measures

Primary Outcomes (1)

Least Squares Mean Change in Serum Potassium From Baseline to Week 4 or Time of First Titration for Each Individual Starting Dose Group
Least square mean changes from Baseline to Week 4/first titration were derived from parallel lines ANCOVA model with randomized starting dose and baseline serum potassium value as covariates.
Baseline to Week 4 or First Titration which could occur at any scheduled study visit after patiromer initiation.

Secondary Outcomes (8)

Least Squares Mean Change in Serum Potassium From Baseline to Week 8 or Time of First Titration for Each Individual Starting Dose Group
Baseline to Week 8 or First Titration which could occur at any scheduled study visit after patiromer initiation.
Least Squares Mean Change in Serum Potassium From Baseline to Day 3 During the Treatment Initiation Period for Each Individual Starting Dose Group
Baseline to Day 3
Mean Change in Serum Potassium From Baseline to Week 52 During the Long-term Maintenance Period for Each Individual Starting Dose Group
Baseline to Week 52
Mean Change in Serum Potassium From Week 52 or Last Patiromer Dose (if Occurred Before Week 52) to Follow-up Visits Plus 7 Days
Week 52 or Last Patiromer Dose (if Occurred before Week 52) to Following up Visit Plus 7 Days
Proportion of Participants Achieving Serum Potassium Levels Within 3.5 to 5.5 mEq/L at Week 8 for Each Individual Starting Dose Group
Baseline to Week 8
+3 more secondary outcomes