End Stage Renal DiseaseABChDNCT02334267

Acid-Base Composition With Use of hemoDialysates

A study testing Group 1: GranuFlo and Group 2: NaturaLyte in people with End Stage Renal Disease, run by Fresenius Medical Care North America at 1 site 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

This study is a prospective, single center, single blind (patient and laboratory), randomized, cross-over, two week investigation of intradialytic acid-base kinetics and physiology associated with use of two commercial acid dialysate concentrates in prevalent hemodialysis patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: End Stage Renal Disease
What is being tested?: Group 1: GranuFlo and Group 2: NaturaLyte
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: Nov 2014to Sep 2015
Phase: Interventional
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subjects eligible to be entered into this study will meet all of the following criteria:
Adult female or male patients; age ≥18 years.
End stage renal disease (ESRD) patients treated for >90 days with the modality of maintenance hemodialysis and on a stable dialysis prescription for the prior month.
Patients utilizing a hemodialysis vascular access of a functioning arteriovenous fistula (AVF) or graft (AVG) during the prior month. The patient's AVF/AVG must be considered in stable functioning condition and not be expected to require any surgical revision/intervention during participation in the trial.
Patients with an average spKt/V of ≥1.2 during 30 days prior to screening as determined by historic monthly laboratory adequacy measurements; for patients with only one available spKt/V an average will not be performed. (Note: spKt/V should not be captured from dialysis machine adequacy measurements.)
Screening hemoglobin level of ≥9 g/dL, and investigator considers hemoglobin levels to have been clinically stable for at least 30 days.

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A sodium bicarbonate basic dialysate prescription that has not had any changes for 30 days prior to randomization, and is anticipated to be unchanged during study participation as determined by the investigator.
Unchanged heparin dosing regimen for the past 30 days prior to randomization and anticipated unchanged heparin dosing during participation in this clinical trial.
No changes two weeks prior to randomization or anticipated changes throughout the study in any phosphate binders, calcium supplements, anticoagulant therapies that are not used for hemodialysis treatment (e.g. warfarin, dabigatran, apixaban, rivaroxaban and acetylsalicylic acid (ASA)), non-dialysate sodium bicarbonate and/or citrate based concomitant medications.
If treated with systemic glucocorticoid/corticosteroid medications, no dose changes in the previous two months before randomization, or anticipated dose changes throughout the study duration; the dosing regimen should be consistent with maintenance therapy (i.e. not for an acute or active uncontrolled disease) as determined by the investigator. (Note: this criteria does not pertain to inhaled and/or topical glucocorticoid/corticosteroid therapies)
During the two weeks prior to screening, an average of no more than 3.5 kg in pre-dialysis weight gain. In the event greater than 3.5 kg is noted, the investigator will discuss the specific medical history with the Medical Monitor prior to enrollment.
Willing to comply with all study procedures and be available for the duration of the study.

Who cannot join

Patients that meet any of the following criteria will be ineligible for this study:
Patients unable to provide a signed and dated informed consent for this clinical research study.
Pregnant or lactating female patients.
Females of reproductive potential who do not agree to use a highly effective method of contraception, as determined by the investigator.
Missed a scheduled outpatient dialysis treatment within two weeks prior to screening or anticipated to not attend any prescribed hemodialysis treatments during participation in the study.
Screening or historic laboratory values of aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) levels ≥ 2 times the upper limit of normal. These blood laboratory tests must have been performed within 30 days prior to screening or prior to randomization.

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A screening or historic laboratory value of total bilirubin >1.9 mg/dL that was collected within 30 days prior to screening or obtained before randomization.
Uncontrolled clinically significant blood pressure as determined by the investigator within 30 days prior to screening.
Active or recent bleeding disorder within the past 30 days.
Screening or historic platelet count <100,000 platelets per microliter (mcL) that was collected within 30 days prior to screening or before randomization.
Chronic supplemental oxygen use within 30 days prior to randomization.
Current active and significant chronic obstructive pulmonary disease (COPD) as determined by the investigator.
Significant residual renal function as determined by the investigator. If the amount of residual renal function is in doubt, a 24 hour urine will be collected during the clinic admission to confirm the creatinine clearance. Decisions will be made after the results have been obtained as to the inclusion of data for these subjects.
Active malignancy or a malignancy within the past five years, with exceptions for basal and squamous cell carcinoma.
Active and clinically uncontrolled autoimmune disease as determined by the investigator. Subjects with controlled autoimmune diseases must be considered to be clinically stable in the opinion of the investigator (e.g. subjects with systemic lupus erythematosus (SLE) and no recent flares are not excluded). The investigator will consult with the referring physician if it is necessary to confirm the stability of an autoimmune disease.
Diagnosed with human immunodeficiency virus (HIV).
Diagnosed with congestive heart failure (CHF) class III or IV as classified by the New York Heart Association (NYHA) (refer to Appendix A) within the past 60 days.
Planned or anticipated need for any surgical procedures during participation in the study.
Current or recent illicit drug use or alcohol abuse as determined by the investigator.
Subjects that have any significant medical condition as determined by the investigator, which make her/him ineligible for the study (e.g. clinically significant vomiting on dialysis which affects acid-base status).
Any condition as determined by the investigator that would place the subject at an increased risk, or preclude the subject's full compliance with the study procedures and visits.
Treatment with an investigational drug, device or intervention within 30 days prior to and during participation in this clinical trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Volunteer Research Group and New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920

Other trials in United States

About this study

Official title: Acid-Base Composition With Use of hemoDialysates: the ABChD Trial

Read the detailed description

Approximately 10-20 prevalent hemodialysis patients will be recruited. Subjects will randomized to receive one weekly hemodialysis treatment using each of the two acetate acid dialysate buffers of NaturaLyte and GranuFlo, which will be assigned in a random fashion. Acetate and bicarbonate concentrations will be assessed before, at eight time points during, and six time points after the completion of hemodialysis.

Conditions: End Stage Renal Disease
Being tested: Group 1: GranuFlo, Group 2: NaturaLyte
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.

Group 1: GranuFloDevice
Also called GranuFlo 45X
Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.
Group 2: NaturaLyteDevice
Also called NaturaLyte 45X
Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Study groups in NCT02334267
Study group	Role	What they receive
Group 1: GranuFlo	Active comparator	Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments. Receives: Device: Group 1: GranuFlo
Group 2: NaturaLyte	Active comparator	Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments. Receives: Device: Group 2: NaturaLyte

What is being measured

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

Peridialytic Arterialized Blood Bicarbonate Concentrations
Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations
Measured: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis
Peridialytic Venous Blood Bicarbonate Concentrations
Quantification of Peridialytic Venous Blood Bicarbonate Concentrations
Measured: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis
Peridialytic Arterialized Blood Acetate Concentrations
Quantification of Peridialytic Arterialized Blood Acetate Concentrations
Measured: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis
Peridialytic Venous Blood Acetate Concentrations
Quantification of Peridialytic Venous Blood Acetate Concentrations
Measured: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis

Timeline

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

Nov 2014Sep 2015

First posted8 Jan 2015 (estimated)
Study startNov 2014
Primary completionFeb 2015
Study completionSep 2015

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.
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 N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02334267
Sponsor's protocol ID: ABChD
Acronym: ABChD
Status last verified: Jan 2017
First submitted: 11 Dec 2014
Last updated: 9 Mar 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Smith WB, Gibson S, Newman GE, Hendon KS, Askelson M, Zhao J, Hantash J, Flanagan B, Larkin JW, Usvyat LA, Thadhani RI, Maddux FW. The dynamics of the metabolism of acetate and bicarbonate associated with use of hemodialysates in the ABChD trial: a phase IV, prospective, single center, single blind, randomized, cross-over, two week investigation. BMC Nephrol. 2017 Aug 29;18(1):273. doi: 10.1186/s12882-017-0683-6.
PubMed 28851317

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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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Acid-Base Composition With Use of hemoDialysates: the ABChD Trial
ClinicalTrials.gov ID: NCT02334267
Acronym / sponsor ID: ABChD / ABChD
Conditions: End Stage Renal Disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Fresenius Medical Care North AmericaIndustry (pharma, biotech, devices)
Study start: Nov 2014
Primary completion: Feb 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 8 Jan 2015 (estimated)
Results: Posted 9 Mar 2017

Clinical summary

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

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group 1: GranuFlo	Active comparator	Device: Group 1: GranuFloStudy subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of NaturaLyte for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.
Group 2: NaturaLyte	Active comparator	Device: Group 2: NaturaLyteStudy subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using acid dialysate concentrations of GranuFlo for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.

Who may qualify

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

Key inclusion criteria (12 listed)

Adult female or male patients; age ≥18 years.
End stage renal disease (ESRD) patients treated for >90 days with the modality of maintenance hemodialysis and on a stable dialysis prescription for the prior month.
Patients utilizing a hemodialysis vascular access of a functioning arteriovenous fistula (AVF) or graft (AVG) during the prior month. The patient's AVF/AVG must be considered in stable functioning condition and not be expected to require any surgical revision/intervention during participation in the trial.
Patients with an average spKt/V of ≥1.2 during 30 days prior to screening as determined by historic monthly laboratory adequacy measurements; for patients with only one available spKt/V an average will not be performed. (Note: spKt/V should not be captured from dialysis machine adequacy measurements.)
Screening hemoglobin level of ≥9 g/dL, and investigator considers hemoglobin levels to have been clinically stable for at least 30 days.

Key exclusion criteria (22 listed)

Patients unable to provide a signed and dated informed consent for this clinical research study.
Pregnant or lactating female patients.
Females of reproductive potential who do not agree to use a highly effective method of contraception, as determined by the investigator.
Missed a scheduled outpatient dialysis treatment within two weeks prior to screening or anticipated to not attend any prescribed hemodialysis treatments during participation in the study.
Screening or historic laboratory values of aspartate aminotransferase (AST), alanine transaminase (ALT), and alkaline phosphatase (ALP) levels ≥ 2 times the upper limit of normal. These blood laboratory tests must have been performed within 30 days prior to screening or prior to randomization.

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
Group 1: GranuFloAlso: GranuFlo 45XStudy subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.	Device	Group 1: GranuFlo
Group 2: NaturaLyteAlso: NaturaLyte 45XStudy subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.	Device	Group 2: NaturaLyte

Primary outcome

Peridialytic Arterialized Blood Bicarbonate Concentrations
Time frame: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis
Quantification of Peridialytic Arterialized Blood Bicarbonate Concentrations
Peridialytic Venous Blood Bicarbonate Concentrations
Time frame: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis
Quantification of Peridialytic Venous Blood Bicarbonate Concentrations
Peridialytic Arterialized Blood Acetate Concentrations
Time frame: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis
Quantification of Peridialytic Arterialized Blood Acetate Concentrations
Peridialytic Venous Blood Acetate Concentrations
Time frame: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis
Quantification of Peridialytic Venous Blood Acetate Concentrations

Results and safety

Results posted to the registry on 9 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1 Week 1 GranuFlo and Week 2 NaturaLyte	6	5
Group 2 Week 1 NaturaLyte and Week 2 GranuFlo	5	5

Primary outcome: Peridialytic Arterialized Blood Bicarbonate Concentrations

Time frame: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis. Mean (Standard Deviation). Unit: mEq/l

Measure	GranuFlo n = 10	NaturaLyte n = 10
Pre-dialysis	25.7 (3.33)	27.1 (3.28)
25 min of dialysis	27.2 (3.16)	27.4 (3.69)
60 min of dialysis	28.9 (3.48)	28.4 (4.20)
90 min of dialysis	29.2 (3.85)	28.6 (4.14)
120 min of dialysis	29.3 (3.89)	28.3 (3.95)
150 min of dialysis	29.2 (3.77)	28.3 (3.80)
180 min of dialysis	29.6 (4.09)	28.3 (3.71)
210 min of dialysis	30.1 (3.90)	29.1 (3.90)

GranuFlo vs NaturaLyte: p <0.0001, Mixed Models Analysis

Population analysed: Per Protocol Population

Primary outcome: Peridialytic Venous Blood Bicarbonate Concentrations

Time frame: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis. Mean (Standard Deviation). Unit: mEq/l

Measure	GranuFlo n = 10	NaturaLyte n = 10
25 min of dialysis	29.4 (3.13)	30.8 (3.71)
60 min of dialysis	30.7 (3.83)	30.7 (3.89)
90 min of dialysis	30.2 (3.36)	31.2 (3.71)
120 min of dialysis	30.7 (3.30)	30.6 (3.69)
150 min of dialysis	30.8 (3.58)	30.4 (3.84)
180 min of dialysis	31.0 (3.83)	31.3 (3.65)
210 min of dialysis	30.3 (3.94)	31.0 (3.89)
240 min of dialysis	30.6 (3.92)	30.9 (3.96)

GranuFlo vs NaturaLyte: p = 0.4, Mixed Models Analysis

Population analysed: Per Protocol Population

Primary outcome: Peridialytic Arterialized Blood Acetate Concentrations

Measure	GranuFlo n = 10	NaturaLyte n = 10
Pre-dialysis	0.4 (0.35)	0.4 (0.32)
25 min of dialysis	0.5 (0.29)	0.4 (0.28)
60 min of dialysis	0.3 (0.22)	0.2 (0.12)
90 min of dialysis	0.4 (0.57)	0.1 (0.12)
120 min of dialysis	0.3 (0.18)	0.1 (0.18)
150 min of dialysis	0.2 (0.18)	0.1 (0.12)
180 min of dialysis	0.2 (0.20)	0.1 (0.11)
210 min of dialysis	0.3 (0.21)	0.2 (0.31)

GranuFlo vs NaturaLyte: p = 0.003, Mixed Models Analysis

Population analysed: Per Protocol Population

Primary outcome: Peridialytic Venous Blood Acetate Concentrations

Time frame: 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis. Mean (Standard Deviation). Unit: mmol/L

Measure	GranuFlo n = 10	NaturaLyte n = 10
25 min of dialysis	1.7 (0.62)	1.0 (0.48)
60 min of dialysis	1.6 (0.60)	1.0 (0.52)
90 min of dialysis	1.6 (0.81)	0.9 (0.62)
120 min of dialysis	2.0 (0.74)	1.0 (0.82)
150 min of dialysis	1.8 (0.67)	1.1 (0.65)
180 min of dialysis	1.8 (0.70)	1.1 (0.76)
210 min of dialysis	1.9 (0.83)	1.1 (0.85)
240 min of dialysis	1.7 (0.90)	1.2 (0.84)

GranuFlo vs NaturaLyte: p <0.0001, Mixed Models Analysis

Population analysed: Per Protocol Population

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GranuFlo	0 of 10 (0%)	0 of 10 (0%)	Not reported
NaturaLyte	0 of 11 (0%)	1 of 11 (9.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28851317Smith WB, Gibson S, Newman GE, Hendon KS, Askelson M, Zhao J, Hantash J, Flanagan B, Larkin JW, Usvyat LA, Thadhani RI, Maddux FW. The dynamics of the metabolism of acetate and bicarbonate associated with use of hemodialysates in the ABChD trial: a phase IV, prospective, single center, single blind, randomized, cross-over, two week investigation. BMC Nephrol. 2017 Aug 29;18(1):273. doi: 10.1186/s12882-017-0683-6.
Individual participant dataSharing planned: No

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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.

William B Smith, MD principal investigator

Volunteer Research Group and New Orleans Center for Clinical Research

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

Questions about this trial

What is this clinical trial studying?

A study testing Group 1: GranuFlo and Group 2: NaturaLyte in people with End Stage Renal Disease, run by Fresenius Medical Care North America 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 12 inclusion and 22 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 9 Mar 2017. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Mar 2017). 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?

Peridialytic Arterialized Blood Bicarbonate Concentrations (time frame: Immediately prior to initiation of hemodialysis, and 25, 60, 90, 120, 150, 180, 210, 240 minutes of hemodialysis and 15, 30, 45, 60, 75, and 90 minutes post hemodialysis). The study lists 4 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 NCT02334267, 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 9 Mar 2017.