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Patiromer With or Without Food for the Treatment of Hyperkalemia (TOURMALINE)

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ClinicalTrials.gov Identifier: NCT02694744
Recruitment Status : Completed
First Posted : February 29, 2016
Results First Posted : November 20, 2017
Last Update Posted : May 12, 2021
Sponsor:
Information provided by (Responsible Party):
Vifor Pharma ( Relypsa, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hyperkalemia
Intervention Drug: patiromer
Enrollment 114
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Group 1 - Dosing Without Food Group 2 - Dosing With Food
Hide Arm/Group Description

Patiromer dosing without food

patiromer: 8.4 g/day starting dose, administered orally

Patiromer dosing with food

patiromer: 8.4 g/day starting dose, administered orally

Period Title: Overall Study
Started 57 57
Safety Population [1] 57 56
ITT [2] 57 55
Completed 51 52
Not Completed 6 5
Reason Not Completed
Adverse Event             2             1
Withdrawal by Subject             2             1
Physician Decision             1             2
Lost to Follow-up             1             0
Taking potassium supplement: exclusion 6             0             1
[1]
Safety Population: All subjects who have taken at least one dose of patiromer.
[2]
Two randomized participates from Group 2 were excluded from the analyses for the ITT population.
Arm/Group Title Group 1 - Dosing Without Food Group 2 - Dosing With Food Total
Hide Arm/Group Description

Patiromer dosing without food

patiromer: 8.4 g/day starting dose, administered orally

Patiromer dosing with food

patiromer: 8.4 g/day starting dose, administered orally

*Note: Two randomized participants in Group 2 -Dosing With Food were excluded from the analyses for the intent-to-treat (ITT) population. One participant who did not receive any patiromer dose. Another participant had an important protocol violation and had no post-baseline serum K+, and was excluded from ITT prior to unblinding.

Total of all reporting groups
Overall Number of Baseline Participants 57 55 112
Hide Baseline Analysis Population Description
The intent-to-treat (ITT) population for analysis included all subjects who were randomized and had taken at least one dose of patiromer.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 112 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  33.3%
20
  36.4%
39
  34.8%
>=65 years
38
  66.7%
35
  63.6%
73
  65.2%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 57 participants 55 participants 112 participants
69
(26 to 89)
66
(48 to 94)
67
(26 to 94)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 112 participants
Female
17
  29.8%
22
  40.0%
39
  34.8%
Male
40
  70.2%
33
  60.0%
73
  65.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 112 participants
Hispanic or Latino
33
  57.9%
30
  54.5%
63
  56.3%
Not Hispanic or Latino
24
  42.1%
25
  45.5%
49
  43.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 57 participants 55 participants 112 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
2
   3.6%
2
   1.8%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  10.5%
8
  14.5%
14
  12.5%
White
48
  84.2%
44
  80.0%
92
  82.1%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
3
   5.3%
1
   1.8%
4
   3.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 57 participants 55 participants 112 participants
57 55 112
1.Primary Outcome
Title Percentage of Subjects With Serum Potassium in the Target Range (3.8 - 5.0 mEq/L) at Either Week 3 or Week 4
Hide Description [Not Specified]
Time Frame 21 to 28 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat (ITT) population for efficacy analyses includes all subjects who have been randomized and have taken at least one dose of patiromer.
Arm/Group Title Group 1 - Dosing Without Food Group 2 - Dosing With Food
Hide Arm/Group Description:

Patiromer dosing without food

patiromer: 8.4 g/day starting dose, administered orally

Patiromer dosing with food

patiromer: 8.4 g/day starting dose, administered orally

Overall Number of Participants Analyzed 57 55
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
82.5
(70.1 to 91.3)
87.3
(75.5 to 94.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 - Dosing Without Food, Group 2 - Dosing With Food
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Other Statistical Analysis If the 95% confidence interval for the w/out food Arm overlapped the confidence interval for the w/ food Arm, the study will conclude that there is no evidence of a statistically significant difference between treatment arms.
2.Secondary Outcome
Title Mean Change in Serum Potassium From Baseline to Week 4
Hide Description An ANCOVA model was used to estimate the mean serum potassium change from Baseline to Week 4 with baseline serum potassium as a covariate and treatment group, race (white vs all others), and history of Type 1 or 2 diabetes mellitus (yes or no) as factors in the model.
Time Frame Baseline to Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
Only intent-to-treat subjects who were available at both Baseline and Week 4 visits.
Arm/Group Title Group 1 Group 2
Hide Arm/Group Description:
Patiromer without Food
Patiromer with Food
Overall Number of Participants Analyzed 51 49
Least Squares Mean (Standard Error)
Unit of Measure: mEq/L
-0.62  (0.094) -0.65  (0.088)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1, Group 2
Comments Estimation of mean change in serum potassium from Baseline to week 4.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7893
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 0.03
Confidence Interval (2-Sided) 95%
-0.17 to 0.22
Estimation Comments [Not Specified]
Time Frame Beginning from the time the subject signs the informed consent form until the subject's last study visit, up to 6 weeks.
Adverse Event Reporting Description Treatment emergets AEs (TEAEs) and SAEs were coded in accordance with MedDRA version (18.1). A TEAE is defined as any AE that newly appeared or worsened in severity following initiation of study drug administration.
 
Arm/Group Title Group 1 - Dosing Without Food Group 2 - Dosing With Food
Hide Arm/Group Description

Patiromer dosing without food

patiromer: 8.4 g/day starting dose, administered orally

Patiromer dosing with food

patiromer: 8.4 g/day starting dose, administered orally

*Note - One randomized participant was excluded from the analysis as this participant did not receive any patiromer dose.

All-Cause Mortality
Group 1 - Dosing Without Food Group 2 - Dosing With Food
Affected / at Risk (%) Affected / at Risk (%)
Total   1/57 (1.75%)   0/56 (0.00%) 
Hide Serious Adverse Events
Group 1 - Dosing Without Food Group 2 - Dosing With Food
Affected / at Risk (%) Affected / at Risk (%)
Total   4/57 (7.02%)   1/56 (1.79%) 
Blood and lymphatic system disorders     
Anaemia  1  1/57 (1.75%)  0/56 (0.00%) 
Cardiac disorders     
Angina pectoris  1  0/57 (0.00%)  1/56 (1.79%) 
Cardio-respiratory arrest  1  1/57 (1.75%)  0/56 (0.00%) 
Renal and urinary disorders     
Acute kidney injury  1  1/57 (1.75%)  0/56 (0.00%) 
Vascular disorders     
Intermittent claudication  1  1/57 (1.75%)  0/56 (0.00%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Group 1 - Dosing Without Food Group 2 - Dosing With Food
Affected / at Risk (%) Affected / at Risk (%)
Total   4/57 (7.02%)   8/56 (14.29%) 
Gastrointestinal disorders     
Diarrhoea  1  3/57 (5.26%)  3/56 (5.36%) 
Investigations     
Blood Creatine Phosphokinase Increased  1  1/57 (1.75%)  3/56 (5.36%) 
Nervous system disorders     
Headache  1  0/57 (0.00%)  3/56 (5.36%) 
1
Term from vocabulary, MedDRA (18.1)
Indicates events were collected by systematic assessment
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.
Our agreements generally provide that PI cannot publish single site data before publication of the multi-site publication, unless 1 year has elapsed since completion of the study at all sites. Thereafter, PI may publish provided that PI shall: provide a copy of the publication to sponsor at least 60 days in advance of submission for publication; delete sponsor's confidential information as requested; and delay publication up to an additional 90 days to permit protection of intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Information
Organization: Relypsa, Inc.
Phone: 1-844-relypsa
EMail: medinfo@relypsa.com
Layout table for additonal information
Responsible Party: Vifor Pharma ( Relypsa, Inc. )
ClinicalTrials.gov Identifier: NCT02694744    
Other Study ID Numbers: RLY5016-401
First Submitted: February 25, 2016
First Posted: February 29, 2016
Results First Submitted: July 11, 2017
Results First Posted: November 20, 2017
Last Update Posted: May 12, 2021