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Clinical Trial Results:
A Two-Part, Single-Blind, Phase 3 Study Evaluating the Efficacy and Safety of Patiromer for the Treatment of Hyperkalemia

Summary
EudraCT number	2012-001956-20
Trial protocol	HU CZ SI BG IT DK
Global end of trial date	06 Aug 2013

Results information
Results version number	v1(current)
This version publication date	04 Apr 2016
First version publication date	31 Jul 2015
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

RLY5016-301

ISRCTN number

-

US NCT number

NCT01810939

WHO universal trial number (UTN)

-

Sponsor organisation name

Relypsa, Inc

Sponsor organisation address

100 Cardinal Way, Redwood City, United States, 94063

Public contact

Medical Information, Relypsa, Inc., medinfo@relypsa.com

Scientific contact

Medical Information, Relypsa, Inc., medinfo@relypsa.com

Is trial part of an agreed paediatric investigation plan (PIP)

No

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

No

Analysis stage

Final

Date of interim/final analysis

01 Oct 2013

Is this the analysis of the primary completion data?

Yes

Primary completion date

29 Jul 2013

Global end of trial reached?

Yes

Global end of trial date

06 Aug 2013

Was the trial ended prematurely?

No

Main objective of the trial

Part A: To evaluate the efficacy and safety of patiromer for the treatment of hyperkalemia (K+). Part B: To evaluate the effect of withdrawing patiromer on serum potassium control; To assess whether chronic treatment with patiromer prevents the recurrence of hyperkalemia To provide placebo-controlled safety data.

Protection of trial subjects

This study was conducted in accordance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.

Background therapy

-

Evidence for comparator

-

Actual start date of recruitment

20 Feb 2013

Long term follow-up planned

No

Independent data monitoring committee (IDMC) involvement?

No

Number of subjects enrolled per country

Country: Number of subjects enrolled

Slovenia: 6

Country: Number of subjects enrolled

Czech Republic: 2

Country: Number of subjects enrolled

Denmark: 8

Country: Number of subjects enrolled

Hungary: 33

Country: Number of subjects enrolled

Italy: 6

Country: Number of subjects enrolled

United States: 22

Country: Number of subjects enrolled

Georgia: 79

Country: Number of subjects enrolled

Ukraine: 63

Country: Number of subjects enrolled

Serbia: 14

Country: Number of subjects enrolled

Croatia: 10

Worldwide total number of subjects

243

EEA total number of subjects

65

Number of subjects enrolled per age group

In utero

0

Preterm newborn - gestational age < 37 wk

0

Newborns (0-27 days)

0

Infants and toddlers (28 days-23 months)

0

Children (2-11 years)

0

Adolescents (12-17 years)

0

Adults (18-64 years)

112

From 65 to 84 years

131

85 years and over

0

Subject disposition

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Recruitment details

-

Screening details

Participants were 18 - 80 years of age with hyperkalemia, chronic kidney disease and on stable dose of at least one renin angiotensin aldosterone system inhibitor medication.

Period 1 title

Part A Treatment Period

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Part A Patiromer

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Patiromer

Investigational medicinal product code

Other name

RLY5016 for Oral Suspension

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Patiromer, 4.2 g or 8.4 g starting dose, orally, twice a day for 4 weeks

Number of subjects in period 1	Part A Patiromer
Started	243
Completed	219
Not completed	24
Consent withdrawn by subject	5
Adverse event, non-fatal	10
Protocol-specified withdrawal criteria (high K+)	3
Protocol-specified withdrawal criteria (eGFR)	2
Non-compliance with study drug	1
Protocol Violation	2
Protocol-specified withdrawal criteria (low K+)	1

Period 2 title

Part B Placebo-Controlled Withdrawal

Is this the baseline period?

No

Allocation method

Randomised - controlled

Blinding used

Single blind

Roles blinded

Subject

Are arms mutually exclusive

Yes

Part B Placebo

Arm description

-

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Placebo, orally, twice a day for 8 weeks

Part B Patiromer

Arm description

-

Arm type

Experimental

Investigational medicinal product name

Patiromer

Investigational medicinal product code

Other name

RLY5016 for Oral Suspension

Pharmaceutical forms

Powder for oral suspension

Routes of administration

Oral use

Dosage and administration details

Subjects continued on the same daily patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks

Number of subjects in period 2 ^[1]	Part B Placebo	Part B Patiromer
Started	52	55
Completed	30	45
Not completed	22	10
Adverse event, serious fatal	1	-
Physician decision	1	1
Consent withdrawn by subject	1	-
Adverse event, non-fatal	1	1
Protocol-specified withdrawal criteria (high K+)	14	2
Protocol-specified withdrawal criteria (K+ result)	2	1
Protocol-specified withdrawal criteria (eGFR)	1	1
Non-compliance with study drug	-	1
Lost to follow-up	-	1
Protocol-specified withdrawal criteria (low K+)	1	2

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: To be eligible for Part B, subjects had to meet all of the following: (1) baseline serum K+ at the beginning of Part A is ≥ 5.5 mEq/L, (2) completed the 4 weeks of dosing with Patiromer in Part A, (3) serum K+ at the Part A Week 4 visit in target range for Part A (≥ 3.8 mEq/L and < 5.1 mEq/L), (4) receiving Patiromer at a dose of 8.4 g/day to 50.4 g/day at the Part A Week 4 visit, and (5) still receiving treatment with a RAASi at the Part A Week 4 visit.

Baseline characteristics

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Reporting group title

Part A Treatment Period

Reporting group description

-

Reporting group values	Part A Treatment Period	Total
Number of subjects	243	243
Age categorical
Units: Subjects
In utero	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0
Newborns (0-27 days)	0	0
Infants and toddlers (28 days-23 months)	0	0
Children (2-11 years)	0	0
Adolescents (12-17 years)	0	0
Adults (18-64 years)	112	112
From 65-84 years	131	131
85 years and over	0	0
Age continuous
Units: years
arithmetic mean (full range (min-max))	64.2 (29 to 80)	-
Gender categorical
Units: Subjects
Female	103	103
Male	140	140

End points

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Reporting group title

Part A Patiromer

Reporting group description

-

Reporting group title

Part B Placebo

Reporting group description

-

Reporting group title

Part B Patiromer

Reporting group description

-

Primary: Change in Serum Potassium from Part A Baseline to Part A Week 4

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End point title

Change in Serum Potassium from Part A Baseline to Part A Week 4 ^[1]

End point description

Includes subjects in the intent to treat population of Part A who had either a local or central laboratory serum potassium result at baseline and at least one weekly post-baseline visit (i.e., Part A Week 1 or later) and excludes six subjects who had no result collected after Part A Day 3.

End point type

Primary

End point timeframe

Part A Baseline to Part A Week 4

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Part A primary efficacy endpoint: The mean (SE) change in serum potassium from Part A Baseline to Part A Week 4 was -1.01 (0.031) mEq/L [95% CI: (-1.07, -0.95)]; this mean reduction in serum potassium was statistically significantly different from zero (p < 0.001).

End point values	Part A Patiromer
Number of subjects analysed	237 ^[2]
Units: mEq/L
least squares mean (standard error)	-1.01 ( 0.031 )

Notes
[2] - Excludes six subjects who had no result collected after Part A Day 3.

No statistical analyses for this end point

Primary: Change in Serum Potassium from Part B Baseline

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End point title

Change in Serum Potassium from Part B Baseline

End point description

Change in Serum Potassium from Part B Baseline to either: Part B Week 4 visit, if the subject’s serum potassium remained ≥ 3.8 mEq/L and < 5.5 mEq/L up to the Part B Week 4 visit or the earliest Part B visit at which the subject’s serum potassium was < 3.8 mEq/L or ≥ 5.5 mEq/L.

End point type

Primary

End point timeframe

Part B Baseline to Part B Week 4 or first local laboratory serum potassium < 3.8 mEq/L or ≥ 5.5 mEq/L

End point values	Part B Placebo	Part B Patiromer
Number of subjects analysed	52	55
Units: mEq/L
median (inter-quartile range (Q1-Q3))	0.72 (0.22 to 1.22)	0 (-0.3 to 0.3)

Difference in Serum Potassium Change in Part B

Statistical analysis description

Test for difference between treatment groups in serum potassium change in Part B

Comparison groups

Part B Placebo v Part B Patiromer

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Confidence interval

Secondary: Proportion of Subjects with Serum Potassium ≥ 5.1 mEq/L in Part B

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End point title

Proportion of Subjects with Serum Potassium ≥ 5.1 mEq/L in Part B

End point description

End point type

Secondary

End point timeframe

Part B Baseline to Part B Week 8

End point values	Part B Placebo	Part B Patiromer
Number of subjects analysed	52	55
Units: percentage of participants	91	43

Difference between Groups in Proportion ≥5.1 mEq/L

Statistical analysis description

Test for difference between treatment groups in proportion with serum potassium ≥ 5.1 mEq/L

Comparison groups

Part B Placebo v Part B Patiromer

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mantel-Haenszel

Confidence interval

Secondary: Proportion of Subjects with Serum Potassium ≥ 5.5 mEq/L in Part B

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End point title

Proportion of Subjects with Serum Potassium ≥ 5.5 mEq/L in Part B

End point description

End point type

Secondary

End point timeframe

Part B Baseline to Part B Week 8

End point values	Part B Placebo	Part B Patiromer
Number of subjects analysed	52	55
Units: percentage of participants	60	15

Difference between Groups in Proportion ≥5.5 mEq/L

Statistical analysis description

Test for difference between treatment groups in proportion with serum potassium ≥ 5.5 mEq/L

Comparison groups

Part B Placebo v Part B Patiromer

Number of subjects included in analysis

107

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mantel-Haenszel

Confidence interval

Adverse events

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Timeframe for reporting adverse events

Up to 2 weeks after end of treatment

Adverse event reporting additional description

Randomized participants who received at least one dose of trial medication

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

12.0

Reporting group title

Part A Patiromer

Reporting group description

Participants were administered 4.2 g or 8.4 g starting dose of patiromer, orally, twice daily, with dose adjustment based on serum potassium, for 4 weeks

Reporting group title

Part B Patiromer

Reporting group description

Participants continued on the same daily Part A patiromer dose as administered at the time of the Part A Week 4 Visit for 8 weeks

Reporting group title

Part B Placebo

Reporting group description

Participants were administered placebo, orally, twice a day for 8 weeks

Serious adverse events	Part A Patiromer	Part B Patiromer	Part B Placebo
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 243 (1.23%)	0 / 55 (0.00%)	1 / 52 (1.92%)
number of deaths (all causes)	0	0	1
number of deaths resulting from adverse events	0	0	0
Investigations
Anticoagulation drug level below therapeutic
subjects affected / exposed	1 / 243 (0.41%)	0 / 55 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	1 / 243 (0.41%)	0 / 55 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Thrombosis mesenteric vessel
subjects affected / exposed	0 / 243 (0.00%)	0 / 55 (0.00%)	1 / 52 (1.92%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1
Renal and urinary disorders
Renal failure chronic
subjects affected / exposed	1 / 243 (0.41%)	0 / 55 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Escherichia bacteraemia
subjects affected / exposed	1 / 243 (0.41%)	0 / 55 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Urinary tract infection
subjects affected / exposed	1 / 243 (0.41%)	0 / 55 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Endocarditis enterococcal
subjects affected / exposed	1 / 243 (0.41%)	0 / 55 (0.00%)	0 / 52 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Part A Patiromer	Part B Patiromer	Part B Placebo
Total subjects affected by non serious adverse events
subjects affected / exposed	33 / 243 (13.58%)	5 / 55 (9.09%)	8 / 52 (15.38%)
Vascular disorders
Hypertension
subjects affected / exposed	4 / 243 (1.65%)	0 / 55 (0.00%)	3 / 52 (5.77%)
occurrences all number	4	0	3
Nervous system disorders
Headache
subjects affected / exposed	2 / 243 (0.82%)	2 / 55 (3.64%)	4 / 52 (7.69%)
occurrences all number	2	2	4
Gastrointestinal disorders
Constipation
subjects affected / exposed	26 / 243 (10.70%)	2 / 55 (3.64%)	0 / 52 (0.00%)
occurrences all number	26	2	0
Infections and infestations
Influenza
subjects affected / exposed	1 / 243 (0.41%)	1 / 55 (1.82%)	3 / 52 (5.77%)
occurrences all number	1	1	3

More information

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Were there any global substantial amendments to the protocol? No

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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