Trial · NCT03888066

Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)

NCT03888066, Phase 3, Completed, Vifor Pharma, Inc.; results first posted 2023-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND). Trials, record NCT03888066. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03888066

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Patiromer for the Management of Hyperkalemia in Subjects Receiving RAASi Medications for the Treatment of Heart Failure (DIAMOND)
NCT number: NCT03888066
Status: Completed
Phases: Phase 3
Enrollment: 1,195 participants, actual
Lead sponsor: Vifor Pharma, Inc.
Conditions: Hyperkalemia
Interventions: Patiromer, Placebos
First posted: 2019-03-25
Last updated: 2023-02-24
Other registries' IDs: eudract:2018-005030-38
Results first posted: 2023-02-24

Source ClinicalTrials.gov

Registered outcomes6

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Changes in Serum K+ Levels From Baseline	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Adjusted mean changes in serum K+ from Baseline.
Secondary	CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	From Day 1/Baseline to week 90	Cumulative incidence of the first event of hyperkalemia with a serum K+ value \>5.5 mEq/l taking death as competing and calculated as CIF Estimates (95% CI) over time. Aalen-Johansen estimators of the cumulative incidence function with death as a competing event. CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter
Secondary	CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time	From Day 1/Baseline to week 102	Cumulative incidence of the reduction of the MRA dose below target dose calculated as CIF Estimates (95% CI) over time. Note: The reduction below the MRA target dose must last for at least 14 days (orless if at the end of study) to confirm this endpoint. CIF = cumulative incidence function; mEq/l = Milliequivalents Per Liter
Secondary	Investigator-reported Events of Hyperkalemia	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Participant's follow-up is from the date of the first dose of randomized study medication up to the participant's end of study date or 24 Jun 2021, whichever comes first. Annualized event rate per 100 subject-years= The total number of events for all subjects in the treatment group divided by the total subject-years of follow-up in that treatment group multiplied by 100.
Secondary	Hyperkalemia-related Hard Outcomes Endpoints	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Analyzed using Win Ratio approach with the following hierarchical components: 1. Time to CV death 2. Total number of CV hospitalizations 3. Total number of hyperkalemia toxicity events with serum K+ \>6.5 mEq/l 4. Total number of hyperkalemia events with serum K+ \>6.0-6.5 mEq/l 5. Total number of hyperkalemia events with serum K+ \>5.0 mEq/l MHTE=More hyperkalemia toxicity events; MHE=More hyperkalemia events; CV=Cardiovascular
Secondary	RAASi Use Score	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	RAASi use score (0 to 8 points) analyzed using the Win Ratio approach for each pair of participants with the following additive components: 1. All-cause death 2. Occurrence of a CV hospitalization 3. HF medication use and dose for i) an ACEi/ARB/ARNi, ii) a MRA, and iii) a beta-blocker Each participant in each comparison can have 0-8 points and all participants are compared using this score at the respective appropriate follow-up time point. RAASi=renin-angiotensin-aldosterone system inhibitor; ACEi=angiotensin converting enzyme inhibitor; ARB=angiotensin receptor blocker; ARNi=angiotensin receptor/neprilysin inhibitor; MRA=mineralocorticoid receptor antagonist.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Changes in Serum K+ Levels From Baseline	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Milliequivalents Per Liter (mEq/l)	LEAST_SQUARES_MEAN
SECONDARY	CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	From Day 1/Baseline to week 90	Probability	NUMBER
SECONDARY	CIF Estimates of the Reduction of the MRA Dose Below Target Dose Over Time	From Day 1/Baseline to week 102	Probability	NUMBER
SECONDARY	Investigator-reported Events of Hyperkalemia	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Ann. event rate per 100 subject-years	NUMBER
SECONDARY	Hyperkalemia-related Hard Outcomes Endpoints	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Events	NUMBER
SECONDARY	RAASi Use Score	Mean duration of exposure: 227.9 days for Patiromer and 234.5 days for Placebo	Events	NUMBER

Source ClinicalTrials.gov

Results by group62

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Changes in Serum K+ Levels From Baseline	Patiromer		0.029	Standard Error 0.019	Milliequivalents Per Liter (mEq/l)
Changes in Serum K+ Levels From Baseline	Placebo		0.127	Standard Error 0.019	Milliequivalents Per Liter (mEq/l)
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Patiromer	Week 1	0.02	95% Confidence Interval 0.01 to 0.04	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Placebo	Week 1	0.04	95% Confidence Interval 0.03 to 0.06	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Patiromer	Week 2	0.04	95% Confidence Interval 0.02 to 0.06	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Placebo	Week 2	0.08	95% Confidence Interval 0.06 to 0.11	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Patiromer	Week 6	0.05	95% Confidence Interval 0.03 to 0.07	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Placebo	Week 6	0.10	95% Confidence Interval 0.08 to 0.13	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Patiromer	Week 18	0.08	95% Confidence Interval 0.06 to 0.12	Probability
CIF Estimates of the Time to First Hyperkalemia Event With Serum K+ Level > 5.5 mEq/l Over Time	Placebo	Week 18	0.14	95% Confidence Interval 0.11 to 0.18	Probability

1 to 10 of 62Source ClinicalTrials.gov

See all 62 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Run-in Phase	STARTED	Patiromer	1,195
Run-in Phase	STARTED	Placebo	0
Run-in Phase	COMPLETED	Patiromer	878
Run-in Phase	COMPLETED	Placebo	0
Run-in Phase	NOT COMPLETED	Patiromer	317
Run-in Phase	NOT COMPLETED	Placebo	0
Treatment Phase (Overall Study)	STARTED	Patiromer	439
Treatment Phase (Overall Study)	STARTED	Placebo	439
Treatment Phase (Overall Study)	COMPLETED	Patiromer	360
Treatment Phase (Overall Study)	COMPLETED	Placebo	367

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events204

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Hypotension	Vascular disorders	Patiromer	15	439	17
other	Hypotension	Vascular disorders	Placebo	13	439	14
other	Hypertension	Vascular disorders	Patiromer	8	439	8
other	Hypertension	Vascular disorders	Placebo	2	439	2
other	Asthenia	General disorders	Patiromer	5	439	5
other	Asthenia	General disorders	Placebo	8	439	9
other	Oedema peripheral	General disorders	Patiromer	2	439	2
other	Oedema peripheral	General disorders	Placebo	5	439	5
other	Gynaecomastia	Reproductive system and breast disorders	Patiromer	6	439	6
other	Gynaecomastia	Reproductive system and breast disorders	Placebo	0	439	0

1 to 10 of 204Source ClinicalTrials.gov

See all 204 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Patiromer	24	439
Total, all-cause mortality	Placebo	18	439
Total, other adverse events	Patiromer	320	439
Total, other adverse events	Placebo	325	439
Total, serious adverse events	Patiromer	54	439
Total, serious adverse events	Placebo	58	439

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
33608263	DERIVED	PubMed
35900838	DERIVED	PubMed
39159624	DERIVED	PubMed
39340493	DERIVED	PubMed
41957746	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Patiromer vs Placebo: deaths from any cause	Trial comparisons
Patiromer vs Placebo: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03888066

GET https://conductscience.org/api/trials/v1/NCT03888066/results?page=2

API reference For AI assistants