End Stage Renal Failure on DialysisPhase 3TWOPLUS-HDNCT03740048

A Pilot Trial of Twice-weekly Versus Thrice-weekly Hemodialysis in Patients With Incident End-stage Kidney Disease

A Phase 3 study testing Hemodialysis and Patiromer Oral Product in people with End Stage Renal Failure on Dialysis, run by Wake Forest University Health Sciences 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

Search all trials

Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: End Stage Renal Failure on Dialysis
What is being tested?: Hemodialysis and Patiromer Oral Product
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 1 siteUnited States
Study dates: 19 Jun 2019to 4 Nov 2021
Phase: Phase 3
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
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Age ≥18 years
Incident ESKD from CKD progression (including a failing renal transplant)
Are deemed to require dialysis initiation by the treating nephrologist
Have elected HD for renal replacement therapy (RRT)

Who cannot join

Have urine output <500ml per day
Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by Acute Kidney Injury Network [AKIN]) criteria)
Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)
Are scheduled to undergo transplantation from a live donor within the next 6 months
Have an active diagnosis of hepatorenal syndrome
Have a significant malignancy that is likely to impact survival
Have a medical condition that would jeopardize the safety of the subject.

Trial locations and contacts

1 site in 1 country.

United States1 site

Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)

The optimal frequency of hemodialysis treatments in patients with incident end-stage kidney disease in not known. This pilot trial will randomize patients with incident end-stage kidney disease due to chronic kidney disease progression to two different regimens of hemodialysis: i) twice-weekly hemodialysis for six weeks with adjuvant pharmacologic medications followed by thrice-weekly hemodialysis, or ii) thrice-weekly hemodialysis. The study will test feasibility of stepwise hemodialysis, and the effects of the two regimens of hemodialysis on residual kidney function.

Conditions: End Stage Renal Failure on Dialysis
Being tested: Hemodialysis, Patiromer Oral Product
Keywords: Hemodialysis, Kidney Disease, Kidney Function
Medical subject headings: Kidney Diseases

What participants receive

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

HemodialysisOther
Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
Patiromer Oral ProductDrug
Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.

Study groups in NCT03740048
Study group	Role	What they receive
Hemodialysis and Pharmacologic Therapy	Experimental	Hemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group) Receives: Other: Hemodialysis; Drug: Patiromer Oral Product
Conventional Hemodialysis Regimen	Active comparator	Hemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis Receives: Other: Hemodialysis

What is being measured

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

Patients' Adherence to Study Protocol
≥95% of participants randomized in the intervention group will adhere to the HD regimen. All participants who completed 6 and 12 months of follow-up completed interdialytic timed urine collections - Patient adherence to the study protocol was assessed by the number of participants randomized to each intervention who adhered to the study protocol and at 6 months and at 12 months
Measured: 6 months, 12 months, 24 months

Secondary outcomes (3)

24-hour Urine Volume
Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed at baseline, 6 Weeks, 12 Weeks and 24 Weeks
Measured: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Change in Residual Kidney Function - Urea Clearance
Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed during weeks 6, 12, and 24.
Measured: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Change in Residual Kidney Function - Creatinine Clearance
Residual renal clearance was calculated based on 24-hour urine collection performed at baseline at enrollment; and interdialytic urine collection performed during weeks 6, 12, and 24.
Measured: Baseline, 6 Weeks, 12 Weeks, 24 Weeks

Timeline

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

19 Jun 20194 Nov 2021

First posted14 Nov 2018
Study start19 Jun 2019
Primary completion4 Nov 2021
Study completion4 Nov 2021

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 (24)Papers the sponsor has linked to this study.
Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
More trials run by Wake Forest University Health SciencesThe 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03740048
Sponsor's protocol ID: IRB00054726
Acronym: TWOPLUS-HD
Status last verified: Apr 2022
First submitted: 9 Nov 2018
Last updated: 9 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: After study completion, de-identified participant data may be provided to other researchers in the filed if requested. The request(s) will be reviewed by the principal investigator and other study members to determine if appropriate.

Publications

National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.
PubMed 26498416
Lowrie EG, Laird NM, Parker TF, Sargent JA. Effect of the hemodialysis prescription on patient morbidity: report from the National Cooperative Dialysis Study. N Engl J Med. 1981 Nov 12;305(20):1176-81. doi: 10.1056/NEJM198111123052003.
PubMed 7027040
Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
PubMed 12490682
Paniagua R, Amato D, Vonesh E, Correa-Rotter R, Ramos A, Moran J, Mujais S. Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial. J Am Soc Nephrol. 2002 May;13(5):1307-1320. doi: 10.1681/ASN.V1351307.
PubMed 11961019
Lo WK, Ho YW, Li CS, Wong KS, Chan TM, Yu AW, Ng FS, Cheng IK. Effect of Kt/V on survival and clinical outcome in CAPD patients in a randomized prospective study. Kidney Int. 2003 Aug;64(2):649-56. doi: 10.1046/j.1523-1755.2003.00098.x.
PubMed 12846762
Li Y, Jin Y, Kapke A, Pearson J, Saran R, Port FK, Robinson BM. Explaining trends and variation in timing of dialysis initiation in the United States. Medicine (Baltimore). 2017 May;96(20):e6911. doi: 10.1097/MD.0000000000006911.
PubMed 28514305
Chin AI, Appasamy S, Carey RJ, Madan N. Feasibility of Incremental 2-Times Weekly Hemodialysis in Incident Patients With Residual Kidney Function. Kidney Int Rep. 2017 Jun 21;2(5):933-942. doi: 10.1016/j.ekir.2017.06.005. eCollection 2017 Sep.
PubMed 29270499
Lin YF, Huang JW, Wu MS, Chu TS, Lin SL, Chen YM, Tsai TJ, Wu KD. Comparison of residual renal function in patients undergoing twice-weekly versus three-times-weekly haemodialysis. Nephrology (Carlton). 2009 Feb;14(1):59-64. doi: 10.1111/j.1440-1797.2008.01016.x. Epub 2008 Nov 19.
PubMed 19019171
Zhang M, Wang M, Li H, Yu P, Yuan L, Hao C, Chen J, Kalantar-Zadeh K. Association of initial twice-weekly hemodialysis treatment with preservation of residual kidney function in ESRD patients. Am J Nephrol. 2014;40(2):140-50. doi: 10.1159/000365819. Epub 2014 Aug 23.
PubMed 25171342
Shafi T, Jaar BG, Plantinga LC, Fink NE, Sadler JH, Parekh RS, Powe NR, Coresh J. Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis. 2010 Aug;56(2):348-58. doi: 10.1053/j.ajkd.2010.03.020. Epub 2010 Jun 3.
PubMed 20605303
Termorshuizen F, Dekker FW, van Manen JG, Korevaar JC, Boeschoten EW, Krediet RT; NECOSAD Study Group. Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol. 2004 Apr;15(4):1061-70. doi: 10.1097/01.asn.0000117976.29592.93.
PubMed 15034110
Marquez IO, Tambra S, Luo FY, Li Y, Plummer NS, Hostetter TH, Meyer TW. Contribution of residual function to removal of protein-bound solutes in hemodialysis. Clin J Am Soc Nephrol. 2011 Feb;6(2):290-6. doi: 10.2215/CJN.06100710. Epub 2010 Oct 28.
PubMed 21030575
Weir MR, Bakris GL, Bushinsky DA, Mayo MR, Garza D, Stasiv Y, Wittes J, Christ-Schmidt H, Berman L, Pitt B; OPAL-HK Investigators. Patiromer in patients with kidney disease and hyperkalemia receiving RAAS inhibitors. N Engl J Med. 2015 Jan 15;372(3):211-21. doi: 10.1056/NEJMoa1410853. Epub 2014 Nov 21.
PubMed 25415805
Bakris GL, Pitt B, Weir MR, Freeman MW, Mayo MR, Garza D, Stasiv Y, Zawadzki R, Berman L, Bushinsky DA; AMETHYST-DN Investigators. Effect of Patiromer on Serum Potassium Level in Patients With Hyperkalemia and Diabetic Kidney Disease: The AMETHYST-DN Randomized Clinical Trial. JAMA. 2015 Jul 14;314(2):151-61. doi: 10.1001/jama.2015.7446.
PubMed 26172895
Pitt B, Bakris GL, Bushinsky DA, Garza D, Mayo MR, Stasiv Y, Christ-Schmidt H, Berman L, Weir MR. Effect of patiromer on reducing serum potassium and preventing recurrent hyperkalaemia in patients with heart failure and chronic kidney disease on RAAS inhibitors. Eur J Heart Fail. 2015 Oct;17(10):1057-65. doi: 10.1002/ejhf.402. Epub 2015 Oct 12.
PubMed 26459796

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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RecruitingPhase 4
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RecruitingPhase 2
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All End Stage Renal Failure on Dialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Pilot Study of Hemodialysis Initiation Comparing Twice-Weekly Hemodialysis Plus Dialysis-Sparing Therapy Versus Thrice-Weekly Hemodialysis (The TWOPLUS-HD Trial)
ClinicalTrials.gov ID: NCT03740048
Acronym / sponsor ID: TWOPLUS-HD / IRB00054726
Conditions: End Stage Renal Failure on Dialysis
Keywords: Hemodialysis, Kidney Disease, Kidney Function
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Wake Forest University Health SciencesUniversity, hospital or other
Study start: 19 Jun 2019 (actual)
Primary completion: 4 Nov 2021 (actual)
Study completion: 4 Nov 2021 (actual)
First posted: 14 Nov 2018 (actual)
Results: Posted 5 Jun 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Hemodialysis and Pharmacologic Therapy	Experimental	Other: Hemodialysis, Drug: Patiromer Oral ProductHemodialysis regimen at the initiation of dialysis treatment: Twice-weekly hemodialysis plus adjunctive pharmacologic therapy (loop diuretic, potassium-binding agent, and sodium bicarbonate) for six consecutive weeks, continued by thrice-weekly hemodialysis (intervention group)
Conventional Hemodialysis Regimen	Active comparator	Other: HemodialysisHemodialysis regimen at the initiation of dialysis treatment: thrice-weekly hemodialysis

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥18 years
Incident ESKD from CKD progression (including a failing renal transplant)
Are deemed to require dialysis initiation by the treating nephrologist
Have elected HD for renal replacement therapy (RRT)

Key exclusion criteria (7 listed)

Have urine output <500ml per day
Have ESKD as a result of severe acute kidney injury (AKI) (stage 3 AKI defined by Acute Kidney Injury Network [AKIN]) criteria)
Abrupt decline in kidney function preceding HD therapy initiation (i.e., if eGFR was ≥30 mL/min/1.73 m2 3 months prior to the initiation of dialysis therapy)
Are scheduled to undergo transplantation from a live donor within the next 6 months
Have an active diagnosis of hepatorenal syndrome

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
HemodialysisHemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.	Other	Conventional Hemodialysis Regimen, Hemodialysis and Pharmacologic Therapy
Patiromer Oral ProductParticipants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.	Drug	Hemodialysis and Pharmacologic Therapy

Primary outcome

Patients' Adherence to Study Protocol
Time frame: 6 months, 12 months, 24 months
≥95% of participants randomized in the intervention group will adhere to the HD regimen. All participants who completed 6 and 12 months of follow-up completed interdialytic timed urine collections - Patient adherence to the study protocol was assessed by the number of participants randomized to each intervention who adhered to the study protocol and at 6 months and at 12 months

3 secondary outcomes

24-hour Urine Volume
Time frame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Change in Residual Kidney Function - Urea Clearance
Time frame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks
Change in Residual Kidney Function - Creatinine Clearance
Time frame: Baseline, 6 Weeks, 12 Weeks, 24 Weeks

Results and safety

Results posted to the registry on 5 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Hemodialysis and Pharmacologic Therapy	23	17
Conventional Hemodialysis Regimen	25	16

Primary outcome: Patients' Adherence to Study Protocol

Time frame: 6 months, 12 months, 24 months. Count of participants. Unit: Participants

Measure	Hemodialysis and Pharmacologic Therapy n = 23	Conventional Hemodialysis Regimen n = 25
Patients adherence to study protocol	22	24
interdialytic timed urine collections at 6 month followup	19	19
interdialytic timed urine collections at 12 month followup	10	10

Population analysed: Participants were censored at death, HD withdrawal, or conversion to peritoneal dialysis. Not included in data analysis were participants who withdrew consent, were withdrawn from the study because of nonadherence to HD treatments, or were lost to follow-up.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Monthly basis up to Year 2. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Hemodialysis and Pharmacologic Therapy	11 of 22 (50%)	0 of 22 (0%)	1 of 22
Conventional Hemodialysis Regimen	12 of 22 (54.5%)	0 of 22 (0%)	6 of 22

Limitations and caveats (from the sponsor): Our results should be interpreted in the context of several limitations. Given (1) the imbalances in baseline characteristics between the 2 groups, (2) the small sample size, and (3) the time-delineated twice-weekly HD, the effect estimates are solely exploratory. Our testing of a time-delineated prescription of twice-weekly HD for 6 weeks may leave lingering concerns as to whether incremental HD with longer periods of twice-weekly HD can be effectively and safely implemented.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26498416National Kidney Foundation. KDOQI Clinical Practice Guideline for Hemodialysis Adequacy: 2015 update. Am J Kidney Dis. 2015 Nov;66(5):884-930. doi: 10.1053/j.ajkd.2015.07.015.
Background: PubMed 7027040Lowrie EG, Laird NM, Parker TF, Sargent JA. Effect of the hemodialysis prescription on patient morbidity: report from the National Cooperative Dialysis Study. N Engl J Med. 1981 Nov 12;305(20):1176-81. doi: 10.1056/NEJM198111123052003.
Background: PubMed 12490682Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
Background: PubMed 11961019Paniagua R, Amato D, Vonesh E, Correa-Rotter R, Ramos A, Moran J, Mujais S. Effects of increased peritoneal clearances on mortality rates in peritoneal dialysis: ADEMEX, a prospective, randomized, controlled trial. J Am Soc Nephrol. 2002 May;13(5):1307-1320. doi: 10.1681/ASN.V1351307.
Background: PubMed 12846762Lo WK, Ho YW, Li CS, Wong KS, Chan TM, Yu AW, Ng FS, Cheng IK. Effect of Kt/V on survival and clinical outcome in CAPD patients in a randomized prospective study. Kidney Int. 2003 Aug;64(2):649-56. doi: 10.1046/j.1523-1755.2003.00098.x.
Background: PubMed 28514305Li Y, Jin Y, Kapke A, Pearson J, Saran R, Port FK, Robinson BM. Explaining trends and variation in timing of dialysis initiation in the United States. Medicine (Baltimore). 2017 May;96(20):e6911. doi: 10.1097/MD.0000000000006911.
Background: PubMed 29270499Chin AI, Appasamy S, Carey RJ, Madan N. Feasibility of Incremental 2-Times Weekly Hemodialysis in Incident Patients With Residual Kidney Function. Kidney Int Rep. 2017 Jun 21;2(5):933-942. doi: 10.1016/j.ekir.2017.06.005. eCollection 2017 Sep.
Background: PubMed 19019171Lin YF, Huang JW, Wu MS, Chu TS, Lin SL, Chen YM, Tsai TJ, Wu KD. Comparison of residual renal function in patients undergoing twice-weekly versus three-times-weekly haemodialysis. Nephrology (Carlton). 2009 Feb;14(1):59-64. doi: 10.1111/j.1440-1797.2008.01016.x. Epub 2008 Nov 19.
Background: PubMed 25171342Zhang M, Wang M, Li H, Yu P, Yuan L, Hao C, Chen J, Kalantar-Zadeh K. Association of initial twice-weekly hemodialysis treatment with preservation of residual kidney function in ESRD patients. Am J Nephrol. 2014;40(2):140-50. doi: 10.1159/000365819. Epub 2014 Aug 23.
Background: PubMed 20605303Shafi T, Jaar BG, Plantinga LC, Fink NE, Sadler JH, Parekh RS, Powe NR, Coresh J. Association of residual urine output with mortality, quality of life, and inflammation in incident hemodialysis patients: the Choices for Healthy Outcomes in Caring for End-Stage Renal Disease (CHOICE) Study. Am J Kidney Dis. 2010 Aug;56(2):348-58. doi: 10.1053/j.ajkd.2010.03.020. Epub 2010 Jun 3.
Background: PubMed 15034110Termorshuizen F, Dekker FW, van Manen JG, Korevaar JC, Boeschoten EW, Krediet RT; NECOSAD Study Group. Relative contribution of residual renal function and different measures of adequacy to survival in hemodialysis patients: an analysis of the Netherlands Cooperative Study on the Adequacy of Dialysis (NECOSAD)-2. J Am Soc Nephrol. 2004 Apr;15(4):1061-70. doi: 10.1097/01.asn.0000117976.29592.93.
Background: PubMed 21030575Marquez IO, Tambra S, Luo FY, Li Y, Plummer NS, Hostetter TH, Meyer TW. Contribution of residual function to removal of protein-bound solutes in hemodialysis. Clin J Am Soc Nephrol. 2011 Feb;6(2):290-6. doi: 10.2215/CJN.06100710. Epub 2010 Oct 28.
Individual participant dataSharing planned: Yes. After study completion, de-identified participant data may be provided to other researchers in the filed if requested. The request(s) will be reviewed by the principal investigator and other study members to determine if appropriate.

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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.

Mariana Murea, MD principal investigator

Wake Forest University Health Sciences

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Hemodialysis and Patiromer Oral Product in people with End Stage Renal Failure on Dialysis, run by Wake Forest University Health Sciences 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 7 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 Jun 2023. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 5 Jun 2023). 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?

Patients' Adherence to Study Protocol (time frame: 6 months, 12 months, 24 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 NCT03740048, which also lists 24 linked publications.

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 Jun 2023.