End Stage Renal DiseasePhase 4NCT00328809
Spironolactone Safety in Dialysis Patients
A Phase 4 study testing spironolactone in people with End Stage Renal Disease and Congestive Heart Failure, run by State University of New York - Upstate Medical University at 1 site in United States.
Trial summary
Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Congestive Heart Failure
- What is being tested?
- spironolactone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2013to 24 Sep 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- They must be at least 18 years of age.
- They must understand the study purpose and give their written informed consent.
- They must have been stable on chronic hemodialysis for at least three months before enrollment into the study.
- Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction.
Who cannot join
- Subjects with primary operable valvular heart disease.
- Subjects with a congenital heart disease.
- Subjects with unstable angina.
- Subjects with primary hepatic failure.
- Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease).
- Subjects who have undergone heart transplantation or who are awaiting heart transplantation are also ineligible.
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- Subjects on a renal transplant list will be accepted into the study until the time of successful renal transplantation and termination of dialysis.
- Subjects with habitually difficult to control hyperkalemia (serum potassium >6.0 meq/L) in the previous month while on dialysis will be excluded.
- The inability to complete the 6-minute walk test will not be a reason to exclude subjects from this study.
Trial locations and contacts
1 site in 1 country.
United States1 site
SUNY Upstate Medical University
Syracuse, New York, 13210
About this study
Official title: Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone
Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.
- Conditions
- End Stage Renal Disease, Congestive Heart Failure
- Being tested
- spironolactone
- Medical subject headings
- Kidney Failure, Chronic, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spironolactoneDrug
spironolactone administered to ESRD patients at low dose
| Study group | Role | What they receive |
|---|---|---|
| Spirnolactone | Experimental | Not described Receives: Drug: spironolactone |
What is being measured
The primary outcome is the main question the study is designed to answer.
risk of hyperkalemia
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study start30 Jun 2013 (estimated)
- Primary completion30 Jun 2017 (estimated)
- Study completion24 Sep 2019
Why it stopped: personnel shortage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- State University of New York - Upstate Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sri Narsipur, State University of New York - Upstate Medical University
- Investigators
- Sriram S Narsipur, MD, Principal investigator, State University of New York - Upstate Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328809
- Sponsor's protocol ID
- 1045057
- Status last verified
- Oct 2020
- First submitted
- 19 May 2006
- Last updated
- 22 Oct 2020
- Results posted
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subjects With Severe Heart Failure and End-Stage Renal Disease on Hemodialysis: A Pilot Study to Assess Safety and Tolerability of Spironolactone
- ClinicalTrials.gov ID
- NCT00328809
- Acronym / sponsor ID
- 1045057
- Conditions
- End Stage Renal Disease, Congestive Heart Failure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: personnel shortage
- Enrolment
- 0 participants (actual)
- Lead sponsor
- State University of New York - Upstate Medical UniversityUniversity, hospital or other
- Study start
- 30 Jun 2013 (estimated)
- Primary completion
- 30 Jun 2017 (estimated)
- Study completion
- 24 Sep 2019 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cardiovascular disease is the leading cause of death and disproportionately prevalent in patients with kidney disease. Spironolactone has been shown to improve survival in the general population with heart failure by up to 30%. We wish to study the safety and tolerability of aldosterone blockade with spironolactone on cardiac function in a high risk population of patients on hemodialysis. We will study and closely monitor subjects over a period of 12 months, during which they will be receiving spironolactone for a period of 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spirnolactone | Experimental | Drug: spironolactone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- They must be at least 18 years of age.
- They must understand the study purpose and give their written informed consent.
- They must have been stable on chronic hemodialysis for at least three months before enrollment into the study.
- Hemodialysis subjects will be included if they have had a left ventricular ejection fraction measured within the past six months with a value no more than 45 percent. A repeat, standardized echocardiogram will be used to confirm left ventricular ejection fraction.
Key exclusion criteria (9 listed)
- Subjects with primary operable valvular heart disease.
- Subjects with a congenital heart disease.
- Subjects with unstable angina.
- Subjects with primary hepatic failure.
- Subjects with active cancer or any life-threatening disease (other than heart failure or end-stage renal disease).
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 |
|---|---|---|
| spironolactonespironolactone administered to ESRD patients at low dose | Drug | Spirnolactone |
Primary outcome
risk of hyperkalemia
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- 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.
Sriram S Narsipur, MD principal investigator
State University of New York - Upstate Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing spironolactone in people with End Stage Renal Disease and Congestive Heart Failure, run by State University of New York - Upstate Medical University at 1 site 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 4 inclusion and 9 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: withdrawn, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
risk of hyperkalemia (time frame: 6 months). 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 NCT00328809, 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 22 Oct 2020.