End-Stage Renal DiseasePhase 2SPin-DNCT02285920

Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent ESRD Trial

A Phase 2 study testing Spironolactone in people with End-Stage Renal Disease, run by University of Pennsylvania at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: End-Stage Renal Disease
What is being tested?: Spironolactone
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 4 sitesUnited States
Study dates: Nov 2014to 30 Jul 2017
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Maintenance hemodialysis therapy for end-stage renal disease
Age 18-85 years
≥3 calendar months since dialysis initiation. Note if a patient has been on dialysis for ≥3 but less than 6 calendar months, there must be no hospitalizations during the 6 weeks prior to screening, and no change in estimated dry weight (EDW) within 2 weeks of the screening date.
For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug.
Ability to provide informed consent

Who cannot join

Serum potassium ≥6.5 mEq/L within the 3 months prior to screening
Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test.
Unscheduled dialysis for hyperkalemia within the 3 months prior to screening
Pre-dialysis systolic blood pressure <100 mm Hg within 2 weeks prior to screening or at the baseline visit
2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure <80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension
Current dual use of angiotensin converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)

Show all 17Show fewer

Current use of digoxin
Current use of spironolactone or eplerenone
Allergy to spironolactone
Inability to maintain dialysis machine blood flow ≥300 mL/min during any of the most recent 3 dialysis sessions prior to the screening visit as an indicator of vascular access dysfunction
Mitral valve repair or replacement
Severe mitral valve disease by echocardiography, coronary angiography or cardiac magnetic resonance imaging
Anticipated kidney transplant, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
Expected survival <9 months
Pregnancy, anticipated pregnancy, or breastfeeding
Incarceration
Participation in another intervention study

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Brigham and Women's Hospital
Boston, Massachusetts, 02120
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Kidney Research Institute, University of Washington
Seattle, Washington, 98104
The George Washington University
Washington D.C., District of Columbia, 20037

Other trials in United States

About this study

Official title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial

The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.

Read the detailed description

The primary objective of this study is to characterize the safety and tolerability of multiple doses of chronic SPL therapy compared with placebo in maintenance hemodialysis patients and to assess the feasibility of conducting a full-scale, mortality-powered trial of SPL. The effects of SPL compared with placebo on multiple cardiovascular efficacy parameters will also be analyzed. The primary efficacy parameter will be the change in the E' measurement on tissue Doppler echocardiography (TDI) as an index of diastolic function and a surrogate for myocardial fibrosis. Secondary cardiac parameters of interest that will be studied in the overall population or in sub-studies include heart rate variability, circulating markers of fibrosis, and coronary flow reserve (CFR) as an index of microvascular function. These parameters are designed to broaden insight into the potential effects of SPL on cardiac structure and function in individuals with dialysis-dependent ESRD and to assess the feasibility of conducting a full-scale, mortality-powered trial.

Conditions: End-Stage Renal Disease
Being tested: Spironolactone
Keywords: hemodialysis, spironolactone, cardiac fibrosis, diastolic function
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SpironolactoneDrug
The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.

Study groups in NCT02285920
Study group	Role	What they receive
Spironolactone 12.5 mg	Active comparator	Participants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks. Receives: Drug: Spironolactone
Spironolactone 25 mg	Active comparator	Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks. Receives: Drug: Spironolactone
Spironolactone 50 mg	Active comparator	Participants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks. Receives: Drug: Spironolactone
Placebo	Placebo comparator	Participants will be treated with placebo for 36 weeks. Receives: Drug: Spironolactone

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety - Number of Participants With Serum Potassium >6.5 mEq/L
The number of participants who had serum potassium >6.5 mEq/L was assessed by treatment arm.
Measured: 0 - 40 weeks
Safety - Participants With Serious Hypotension
The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).
Measured: 0 - 40 weeks
Study Drug Tolerability
Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.
Measured: 0 - 36 weeks
Efficacy - Change in Mitral Annular E' Velocity
Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy.
Measured: Baseline to 36 weeks
Feasibility of Conducting a Full-scale Mortality-powered Trial
An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.
Measured: 0 - 40 weeks

Secondary outcomes (9)

Safety - Number of Participants With Serious Hyperkalemia
Number of patients with serious hyperkalemia requiring hospitalization, emergency/unscheduled dialysis or resin therapy
Measured: 0 - 40 weeks
Safety - Hyperkalemia Requiring Adjustment in Treatment
Hyperkalemia requiring adjustment in dialysate potassium concentration, or discontinuation of study medication
Measured: 0 - 40 weeks
Safety - Inter- or Intra-dialytic Hypotension
Inter- or intra-dialytic hypotension defined as:
1. Inter-dialytic: systolic blood pressure <90 mm Hg or inter-dialytic hypotension requiring adjustment in anti-hypertensive medications or treatment in a hospital or emergency room.
2. Intra-dialytic: systolic blood pressure <80 mm Hg during ≥3 dialysis sessions per 30-day period or treatment for either hypotension or symptoms of hypotension during ≥3 dialysis sessions per 30-day period
Measured: 0 - 40 weeks
Safety - Cardiovascular Death
Number of Cardiovascular deaths defined as death due to myocardial infarction, congestive heart failure, cardiac valvular disease, arrhythmia, sudden death, stroke, or peripheral arterial disease
Measured: 0 - 40 weeks
Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function
- Change in left ventricular ejection fraction between Baseline and 36 weeks
Measured: Baseline - 36 weeks
Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,
- Change in left ventricular mass index (LVMI) between baseline and 36 weeks
Measured: Baseline - 36 weeks
Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,
- E/E' is the ratio of mitral peak velocity of early filling (E) to early diastolic mitral annular velocity (E')
Measured: Baseline - 36 weeks
Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)
Secondary outcome measures include other echocardiographic markers of systolic and diastolic function,
- Change in myocardial strain and strain rate between baseline and 36 weeks
Measured: Baseline - 36 weeks
Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia
The number of participants who had serum potassium >6.5 mEq/L or serious hyperkalemia was assessed by treatment arm.
Measured: 0 - 40 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201430 Jul 2017

First posted7 Nov 2014 (estimated)
Study startNov 2014
Primary completionJun 2017
Study completion30 Jul 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End-Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by University of PennsylvaniaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02285920
Sponsor's protocol ID: 821193
Acronym: SPin-D
Status last verified: Jul 2019
First submitted: 13 Oct 2014
Last updated: 23 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
PubMed 33586138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 23 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Cardiovascular Efficacy of Spironolactone in Dialysis-Dependent End-Stage Renal Disease (ESRD) (SPin-D) Trial
ClinicalTrials.gov ID: NCT02285920
Acronym / sponsor ID: SPin-D / 821193
Conditions: End-Stage Renal Disease
Keywords: hemodialysis, spironolactone, cardiac fibrosis, diastolic function
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 129 participants (actual)
Lead sponsor: University of PennsylvaniaUniversity, hospital or other
Collaborators: Brigham and Women's Hospital, George Washington University, Vanderbilt University, University of Washington
Study start: Nov 2014
Primary completion: Jun 2017 (actual)
Study completion: 30 Jul 2017 (actual)
First posted: 7 Nov 2014 (estimated)
Results: Posted 23 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The SPin-D Trial is a phase II randomized, double-blind, placebo-controlled, multi-center study of spironolactone (SPL) for patients with hemodialysis-dependent end-stage renal disease.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Spironolactone 12.5 mg	Active comparator	Drug: SpironolactoneParticipants will initiate treatment at 12.5 mg daily and continue at this dose for 36 weeks.
Spironolactone 25 mg	Active comparator	Drug: SpironolactoneParticipants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for a total treatment time of 36 weeks.
Spironolactone 50 mg	Active comparator	Drug: SpironolactoneParticipants will initiate treatment at 12.5 mg daily for 2 weeks at which time the dose will be increased to 25 mg daily for 2 weeks, and increased to 50 mg daily for a total treatment time of 36 weeks.
Placebo	Placebo comparator	Drug: SpironolactoneParticipants will be treated with placebo for 36 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Maintenance hemodialysis therapy for end-stage renal disease
Age 18-85 years
≥3 calendar months since dialysis initiation. Note if a patient has been on dialysis for ≥3 but less than 6 calendar months, there must be no hospitalizations during the 6 weeks prior to screening, and no change in estimated dry weight (EDW) within 2 weeks of the screening date.
For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose to study drug.
Ability to provide informed consent

Key exclusion criteria (17 listed)

Serum potassium ≥6.5 mEq/L within the 3 months prior to screening
Serum potassium level ≥6.0 mEq/L within 2 weeks prior to the baseline visit. If a potassium value is not available through routine clinical care during this 2-week period a potassium measurement will be performed as a research test.
Unscheduled dialysis for hyperkalemia within the 3 months prior to screening
Pre-dialysis systolic blood pressure <100 mm Hg within 2 weeks prior to screening or at the baseline visit
2 or more dialysis sessions within the month prior to screening with either 2 intra-dialytic measurements of systolic blood pressure <80 mm Hg or muscle cramping, light-headedness, nausea or hypotension requiring infusion of saline or other intervention directed at hypotension

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SpironolactoneThe trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.	Drug	Placebo, Spironolactone 12.5 mg, Spironolactone 25 mg, Spironolactone 50 mg

Primary outcome

Safety - Number of Participants With Serum Potassium >6.5 mEq/L
Time frame: 0 - 40 weeks
The number of participants who had serum potassium >6.5 mEq/L was assessed by treatment arm.
Safety - Participants With Serious Hypotension
Time frame: 0 - 40 weeks
The number of participants experiencing serious hypotension, defined as hypotension requiring hospitalization or ED visit and not attributable to overt sepsis, acute myocardial infarction, or other cardiovascular event (e.g. aortic dissection).
Study Drug Tolerability
Time frame: 0 - 36 weeks
Tolerability is defined as number of participants who experienced permanent study drug discontinuation or dose reduction.
Efficacy - Change in Mitral Annular E' Velocity
Time frame: Baseline to 36 weeks
Change in mitral annular E' velocity measured using Tissue Doppler Index (TDI) echocardiography. Efficacy outcomes were considered exploratory with a goal of detecting signals rather than clearly demonstrating efficacy.
Feasibility of Conducting a Full-scale Mortality-powered Trial
Time frame: 0 - 40 weeks
An objective of this study is to assess the feasibility of conducting a full-scale mortality-powered trial. Feasibility assessed based on recruitment, dropout and loss to follow-up rates.

9 secondary outcomes

Safety - Number of Participants With Serious Hyperkalemia
Time frame: 0 - 40 weeks
Safety - Hyperkalemia Requiring Adjustment in Treatment
Time frame: 0 - 40 weeks
Safety - Inter- or Intra-dialytic Hypotension
Time frame: 0 - 40 weeks
Safety - Cardiovascular Death
Time frame: 0 - 40 weeks
Efficacy - Secondary Cardiac Outcome Measure - Left Ventricular Ejection Fraction (LVEF)
Time frame: Baseline - 36 weeks
Efficacy - Secondary Cardiac Outcome Measures Left Ventricular Mass Index (LVMI)
Time frame: Baseline - 36 weeks
Efficacy - Secondary Cardiac Outcome Measures - Ratio of Mitral Peak Velocity to Diastolic Mitral Annular Velocity (E/E')
Time frame: Baseline - 36 weeks
Efficacy - Secondary Cardiac Outcome Measures - Left Ventricular Global Longitudinal Strain (LVGLS)
Time frame: Baseline - 36 weeks
Safety - Combined Incidence of Potassium >6.5 mEq/L or Serious Hyperkalemia
Time frame: 0 - 40 Weeks

Results and safety

Results posted to the registry on 23 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	51	47
Spironolactone 12.5 mg	27	23
Spironolactone 25 mg	26	21
Spironolactone 50 mg	25	24

Primary outcome: Safety - Number of Participants With Serum Potassium >6.5 mEq/L

Time frame: 0 - 40 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 51	Spironolactone 12.5 mg n = 27	Spironolactone 25 mg n = 26	Spironolactone 50 mg n = 25
Value	9	4	4	8

Primary outcome: Safety - Participants With Serious Hypotension

Time frame: 0 - 40 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 51	Spironolactone 12.5 mg n = 27	Spironolactone 25 mg n = 26	Spironolactone 50 mg n = 25
Value	0	2	0	3

Primary outcome: Study Drug Tolerability

Time frame: 0 - 36 weeks. Count of participants. Unit: Participants

Measure	Placebo n = 51	Spironolactone 12.5 mg n = 27	Spironolactone 25 mg n = 26	Spironolactone 50 mg n = 25
Value	16	5	6	8

Primary outcome: Efficacy - Change in Mitral Annular E' Velocity

Time frame: Baseline to 36 weeks. Mean (Standard Deviation). Unit: cm/second

Measure	Placebo n = 40	Spironolactone 12.5 mg n = 20	Spironolactone 25 mg n = 15	Spironolactone 50 mg n = 22
Baseline MA E'	7.4 (1.7)	7.6 (1.8)	7.8 (1.9)	7.0 (1.9)
36 Week MA E'	7.5 (1.9)	7.4 (1.9)	7.7 (1.4)	7.3 (1.9)
Change between baseline - 36 weeks	0.1 (1.1)	-0.2 (1.0)	-0.1 (1.2)	0.3 (1.6)

Population analysed: The number of participants analyzed reflects those who had analyzable echocardiogram data at both study time points.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were assessed at each study visit during Weeks 1 - 40 of trial participation.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	27 of 51 (52.9%)	45 of 51 (88.2%)	2 of 51
Spironolactone 12.5 mg	13 of 27 (48.1%)	24 of 27 (88.9%)	0 of 27
Spironolactone 25 mg	13 of 26 (50%)	25 of 26 (96.2%)	2 of 26
Spironolactone 50 mg	12 of 25 (48%)	23 of 25 (92%)	1 of 25

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33586138Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Laura M Dember, MD principal investigator

University of Pennsylvania

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Spironolactone in people with End-Stage Renal Disease, run by University of Pennsylvania at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety - Number of Participants With Serum Potassium >6.5 mEq/L (time frame: 0 - 40 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02285920, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2019.