Hemodialysis ComplicationIIHDNCT03352271
Individualized Incremental Hemodialysis Study
A study testing Individualized Incremental hemodialysis and Conventional thrice weekly hemodialysis in people with Hemodialysis Complication and ESRD, run by Alexandria University at 2 sites in Egypt.
Trial summary
Thrice weekly hemodialysis has been the standard of care all-over the world for end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). Despite being in the era of precision medicine and individualized healthcare, this program doesn't take into account patients with residual kidney function (RKF) who… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hemodialysis Complication, ESRD, Renal Failure
- What is being tested?
- Individualized Incremental hemodialysis and Conventional thrice weekly hemodialysis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jun 2017to 1 Dec 2020
- Phase
- Interventional
- 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
- Patients with stage 5 chronic kidney disease (CKD) with estimated glomerular filtration rate of less than 10 ml/min/1.73m2 (using CKD-EPI equation for eGFR).
- Residual urine volume at least 0.5 L/day or more.
Who cannot join
- Children < 18 years of age.
- Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant.
- Recent (within 3 months) acute kidney injury (AKI).
- Urine output less than 0.5 L/day.
- Active malignancy at time of inclusion.
- Active inflammatory disease with immunosuppressive treatment.
- Decompensated Liver disease, Hepatorenal syndrome.
- Cardiovascular disease defined as: heart failure type IV of the New York Heart Association (NYHA) or Cardiorenal syndrome.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
kidney and Urology Center
Alexandria
Mansoura University
Mansourah, Alexandria Governorate, 21529
About this study
Official title: Comparison of Clinical Outcomes Between Thrice-weekly and Individualized Incremental Hemodialysis in Incident Hemodialysis Patients
Thrice weekly hemodialysis has been the standard of care all-over the world for end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). Despite being in the era of precision medicine and individualized healthcare, this program doesn't take into account patients with residual kidney function (RKF) who don't require a thrice weekly hemodialysis frequency. Incremental hemodialysis (defined as twice weekly hemodialysis initiation in incident hemodialysis patients with residual kidney function) has been raised as an alternative to the conventional thrice weekly dialysis. Retrospective trials has proved safety of a twice weekly initiation with comparative efficacy to the thrice weekly program. Despite that, there is paucity of prospective observational and rarity of randomized controlled trials comparing both regimens. In this study, the investigators tend to provide a more individualized incremental hemodialysis approach to incident hemodialysis patients with residual urine volume and RKF. The investigators will compare the results to ESRD patients initiating a thrice weekly hemodialysis program.
Read the detailed description
This project aims to study the feasibility, safety and efficacy of individualized incremental (twice weekly, once weekly, once/10days or less frequent) hemodialysis (IIHD) initiation versus conventional thrice weekly HD for incident end stage renal disease (ESRD) patients with residual urine volume (RUV > 0.5 L/day, as a reference to residual kidney functions) who chose hemodialysis as their method of renal replacement therapy (RRT).
Incremental HD has been an area of research interest in the past few years with many publications discussing its feasibility and safety for incident HD patients. Smooth transition to dialysis in incident ESRD patients through incremental twice (or even once) weekly dialysis initiation has shown benefits in preservation of residual kidney functions (RKF) in comparison to thrice weekly HD. It has also been proposed as a method of reducing healthcare cost while providing quality healthcare to the patients(1). However, most available data are retrospective analysis, few data are present to compare the results to thrice weekly HD in a randomized controlled or even in a prospective manner. Incremental HD has been also practiced in some parts of Egypt in the last 2-3 years. The investigators will compare outcomes of participants starting a less frequent dialysis program to conventional thrice weekly HD in a multi-center study.
- Conditions
- Hemodialysis Complication, ESRD, Renal Failure
- Being tested
- Individualized Incremental hemodialysis, Conventional thrice weekly hemodialysis
- Keywords
- Incremental hemodialysis, Precision medicine, Individualized care
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Individualized Incremental hemodialysisProcedure or surgery
Individualized Incremental hemodialysis program (twice/week, once/week, once/10days or less frequent) will be provided to incident ESRD patients according to their symptom presentation, clinical examination, investigations and daily urine volume measurement.
Conventional thrice weekly hemodialysisProcedure or surgery
Thrice weekly hemodialysis program, the current standard of care for all patients, as a control
| Study group | Role | What they receive |
|---|---|---|
| Individualized Incremental hemodialysis | Experimental | ESRD patients starting an individualized (twice/week, once/week, once/10 days or less frequent) incremental hemodialysis program. Receives: Procedure: Individualized Incremental hemodialysis |
| Thrice weekly dialysis | Active comparator | ESRD patients initiating a conventional thrice weekly hemodialysis program Receives: Procedure: Conventional thrice weekly hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate after 24 months
To assess and compare Survival rate after 24 months in incident HD patients with individualized incremental HD (IIHD) as an RRT starting regimen, compared to those patients who start RRT with the conventional thrice weekly method.
Measured: 24 months
Secondary outcomes (8)
All-cause hospitalization rate
Rate of hospital admissions and number of days hospitalized for any cause (including cardiovascular events, CVE) during the 24 months.
Measured: 24 months
Preservation of residual kidney function
Preservation of Residual kidney function (time to anuria defined as urine output UOP < 100 ml/day, rate of decline of RKF defined as the slope in decline of daily UOP measured monthly) during the 24 months of follow up.
Measured: 24 months
Development of hypertrophic cardiomyopathy
Using Echocardiography to detect the development of hypertrophic cardiomyopathy
Measured: 24 months
Cost of care
comparing number of hemodialysis sessions in both groups multiplied by the cost of each session.
Measured: 24 months
Estimation of quality of life (QOL)
Comparing Quality of life survey values from Kidney Disease Quality of Life short form, KDQOL-SF v1.3, Arabic version between each group members
Measured: 24 months
Anemia Profile
Mean hemoglobin levels.
Measured: 24 months
Bone-mineral metabolism profile
Mean levels of calcium, phosphorus, parathyroid hormone PTH
Measured: 24 months
Vascular access complications
rate of infection, thrombosis and hematoma formation
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start1 Jun 2017
- Primary completion1 Sep 2020
- Study completion1 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Hemodialysis ComplicationStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Collaborators
- Kidney and urology Center, Mansoura University, Fasila Hemodialysis Center
- Responsible party
- Principal investigator, Mohamed Elrggal, Alexandria University
- Investigators
- Mohamed E Elrggal, MD, Principal investigator, Alexandria UniversityMohamed A Sobh, MD, Study chair, Mansoura UniversityHussein A Sheashaa, MD, Study chair, Mansoura UniversityAhmed F Elkeraie, MD, Study chair, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352271
- Sponsor's protocol ID
- MER17MD
- Acronym
- IIHD
- Status last verified
- Jan 2021
- First submitted
- 16 Nov 2017
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Elrggal ME, Zyada R. Gradual initiation of dialysis as a means to reduce cost while providing quality health care. Nat Rev Nephrol. 2017 Nov;13(11):720. doi: 10.1038/nrneph.2017.135. Epub 2017 Sep 25. No abstract available.
PubMed 28944775Rhee CM, Ghahremani-Ghajar M, Obi Y, Kalantar-Zadeh K. Incremental and infrequent hemodialysis: a new paradigm for both dialysis initiation and conservative management. Panminerva Med. 2017 Jun;59(2):188-196. doi: 10.23736/S0031-0808.17.03299-2. Epub 2017 Jan 13.
PubMed 28090764Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.
PubMed 26867814Obi Y, Eriguchi R, Ou SM, Rhee CM, Kalantar-Zadeh K. What Is Known and Unknown About Twice-Weekly Hemodialysis. Blood Purif. 2015;40(4):298-305. doi: 10.1159/000441577. Epub 2015 Nov 17.
PubMed 26656764Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.
PubMed 26038351Kalantar-Zadeh K, Unruh M, Zager PG, Kovesdy CP, Bargman JM, Chen J, Sankarasubbaiyan S, Shah G, Golper T, Sherman RA, Goldfarb DS. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053/j.ajkd.2014.04.019. Epub 2014 May 17.
PubMed 24840669Vanholder R, Van Biesen W, Lameire N. Is starting hemodialysis on a twice-weekly regimen a valid option? Am J Kidney Dis. 2014 Aug;64(2):165-7. doi: 10.1053/j.ajkd.2014.06.003. No abstract available.
PubMed 25060001Rhee CM, Unruh M, Chen J, Kovesdy CP, Zager P, Kalantar-Zadeh K. Infrequent dialysis: a new paradigm for hemodialysis initiation. Semin Dial. 2013 Nov-Dec;26(6):720-7. doi: 10.1111/sdi.12133. Epub 2013 Sep 9.
PubMed 24016197Libetta C, Esposito P, Dal Canton A. Once-weekly hemodialysis: a single-center experience. Am J Kidney Dis. 2015 Feb;65(2):343. doi: 10.1053/j.ajkd.2014.07.034. No abstract available.
PubMed 25616635Bieber B, Qian J, Anand S, Yan Y, Chen N, Wang M, Wang M, Zuo L, Hou FF, Pisoni RL, Robinson BM, Ramirez SP. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant. 2014 Sep;29(9):1770-7. doi: 10.1093/ndt/gft472. Epub 2013 Dec 8.
PubMed 24322579Diao Z, Zhang D, Dai W, Ding J, Zhang A, Liu W. Preservation of residual renal function with limited water removal in hemodialysis patients. Ren Fail. 2011;33(9):875-7. doi: 10.3109/0886022X.2011.605535. Epub 2011 Aug 8.
PubMed 21819316Elamin S, Abu-Aisha H. Reaching target hemoglobin level and having a functioning arteriovenous fistula significantly improve one year survival in twice weekly hemodialysis. Arab J Nephrol Transplant. 2012 May;5(2):81-6.
PubMed 22612193Fernandez-Lucas M, Teruel-Briones JL, Gomis-Couto A, Villacorta-Perez J, Quereda-Rodriguez-Navarro C. Maintaining residual renal function in patients on haemodialysis: 5-year experience using a progressively increasing dialysis regimen. Nefrologia. 2012;32(6):767-76. doi: 10.3265/Nefrologia.pre2012.Jul.11517. English, Spanish.
PubMed 23169359Hanson JA, Hulbert-Shearon TE, Ojo AO, Port FK, Wolfe RA, Agodoa LY, Daugirdas JT. Prescription of twice-weekly hemodialysis in the USA. Am J Nephrol. 1999;19(6):625-33. doi: 10.1159/000013533.
PubMed 10592355Lin X, Yan Y, Ni Z, Gu L, Zhu M, Dai H, Zhang W, Qian J. Clinical outcome of twice-weekly hemodialysis patients in shanghai. Blood Purif. 2012;33(1-3):66-72. doi: 10.1159/000334634. Epub 2011 Dec 29.
PubMed 22212562
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Clinical Outcomes Between Thrice-weekly and Individualized Incremental Hemodialysis in Incident Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT03352271
- Acronym / sponsor ID
- IIHD / MER17MD
- Conditions
- Hemodialysis Complication, ESRD, Renal Failure
- Keywords
- Incremental hemodialysis, Precision medicine, Individualized care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Collaborators
- Kidney and urology Center, Mansoura University, Fasila Hemodialysis Center
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Dec 2020 (actual)
- First posted
- 24 Nov 2017 (actual)
- 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.
Thrice weekly hemodialysis has been the standard of care all-over the world for end-stage renal disease (ESRD) requiring renal replacement therapy (RRT). Despite being in the era of precision medicine and individualized healthcare, this program doesn't take into account patients with residual kidney function (RKF) who don't require a thrice weekly hemodialysis frequency. Incremental hemodialysis (defined as twice weekly hemodialysis initiation in incident hemodialysis patients with residual kidney function) has been raised as an alternative to the conventional thrice weekly dialysis. Retrospective trials has proved safety of a twice weekly initiation with comparative efficacy to the thrice weekly program. Despite that, there is paucity of prospective observational and rarity of randomized controlled trials comparing both regimens. In this study, the investigators tend to provide a more individualized incremental hemodialysis approach to incident hemodialysis patients with residual urine volume and RKF. The investigators will compare the results to ESRD patients initiating a thrice weekly hemodialysis program.
Detailed description
This project aims to study the feasibility, safety and efficacy of individualized incremental (twice weekly, once weekly, once/10days or less frequent) hemodialysis (IIHD) initiation versus conventional thrice weekly HD for incident end stage renal disease (ESRD) patients with residual urine volume (RUV > 0.5 L/day, as a reference to residual kidney functions) who chose hemodialysis as their method of renal replacement therapy (RRT).
Incremental HD has been an area of research interest in the past few years with many publications discussing its feasibility and safety for incident HD patients. Smooth transition to dialysis in incident ESRD patients through incremental twice (or even once) weekly dialysis initiation has shown benefits in preservation of residual kidney functions (RKF) in comparison to thrice weekly HD. It has also been proposed as a method of reducing healthcare cost while providing quality healthcare to the patients(1). However, most available data are retrospective analysis, few data are present to compare the results to thrice weekly HD in a randomized controlled or even in a prospective manner. Incremental HD has been also practiced in some parts of Egypt in the last 2-3 years. The investigators will compare outcomes of participants starting a less frequent dialysis program to conventional thrice weekly HD in a multi-center study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individualized Incremental hemodialysis | Experimental | Procedure: Individualized Incremental hemodialysisESRD patients starting an individualized (twice/week, once/week, once/10 days or less frequent) incremental hemodialysis program. |
| Thrice weekly dialysis | Active comparator | Procedure: Conventional thrice weekly hemodialysisESRD patients initiating a conventional thrice weekly hemodialysis program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with stage 5 chronic kidney disease (CKD) with estimated glomerular filtration rate of less than 10 ml/min/1.73m2 (using CKD-EPI equation for eGFR).
- Residual urine volume at least 0.5 L/day or more.
Key exclusion criteria (8 listed)
- Children < 18 years of age.
- Patients who were previously on other types of RRT, either on peritoneal dialysis, or on kidney transplant.
- Recent (within 3 months) acute kidney injury (AKI).
- Urine output less than 0.5 L/day.
- Active malignancy at time of inclusion.
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 |
|---|---|---|
| Individualized Incremental hemodialysisIndividualized Incremental hemodialysis program (twice/week, once/week, once/10days or less frequent) will be provided to incident ESRD patients according to their symptom presentation, clinical examination, investigations and daily urine volume measurement. | Procedure or surgery | Individualized Incremental hemodialysis |
| Conventional thrice weekly hemodialysisThrice weekly hemodialysis program, the current standard of care for all patients, as a control | Procedure or surgery | Thrice weekly dialysis |
Primary outcome
Survival rate after 24 months
Time frame: 24 months
To assess and compare Survival rate after 24 months in incident HD patients with individualized incremental HD (IIHD) as an RRT starting regimen, compared to those patients who start RRT with the conventional thrice weekly method.
8 secondary outcomes
All-cause hospitalization rate
Time frame: 24 months
Preservation of residual kidney function
Time frame: 24 months
Development of hypertrophic cardiomyopathy
Time frame: 24 months
Cost of care
Time frame: 24 months
Estimation of quality of life (QOL)
Time frame: 24 months
Anemia Profile
Time frame: 24 months
Bone-mineral metabolism profile
Time frame: 24 months
Vascular access complications
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Background: PubMed 28944775Elrggal ME, Zyada R. Gradual initiation of dialysis as a means to reduce cost while providing quality health care. Nat Rev Nephrol. 2017 Nov;13(11):720. doi: 10.1038/nrneph.2017.135. Epub 2017 Sep 25. No abstract available.
- Background: PubMed 28090764Rhee CM, Ghahremani-Ghajar M, Obi Y, Kalantar-Zadeh K. Incremental and infrequent hemodialysis: a new paradigm for both dialysis initiation and conservative management. Panminerva Med. 2017 Jun;59(2):188-196. doi: 10.23736/S0031-0808.17.03299-2. Epub 2017 Jan 13.
- Background: PubMed 26867814Obi Y, Streja E, Rhee CM, Ravel V, Amin AN, Cupisti A, Chen J, Mathew AT, Kovesdy CP, Mehrotra R, Kalantar-Zadeh K. Incremental Hemodialysis, Residual Kidney Function, and Mortality Risk in Incident Dialysis Patients: A Cohort Study. Am J Kidney Dis. 2016 Aug;68(2):256-265. doi: 10.1053/j.ajkd.2016.01.008. Epub 2016 Feb 9.
- Background: PubMed 26656764Obi Y, Eriguchi R, Ou SM, Rhee CM, Kalantar-Zadeh K. What Is Known and Unknown About Twice-Weekly Hemodialysis. Blood Purif. 2015;40(4):298-305. doi: 10.1159/000441577. Epub 2015 Nov 17.
- Background: PubMed 26038351Wong J, Vilar E, Davenport A, Farrington K. Incremental haemodialysis. Nephrol Dial Transplant. 2015 Oct;30(10):1639-48. doi: 10.1093/ndt/gfv231. Epub 2015 Jun 1.
- Background: PubMed 24840669Kalantar-Zadeh K, Unruh M, Zager PG, Kovesdy CP, Bargman JM, Chen J, Sankarasubbaiyan S, Shah G, Golper T, Sherman RA, Goldfarb DS. Twice-weekly and incremental hemodialysis treatment for initiation of kidney replacement therapy. Am J Kidney Dis. 2014 Aug;64(2):181-6. doi: 10.1053/j.ajkd.2014.04.019. Epub 2014 May 17.
- Background: PubMed 25060001Vanholder R, Van Biesen W, Lameire N. Is starting hemodialysis on a twice-weekly regimen a valid option? Am J Kidney Dis. 2014 Aug;64(2):165-7. doi: 10.1053/j.ajkd.2014.06.003. No abstract available.
- Background: PubMed 24016197Rhee CM, Unruh M, Chen J, Kovesdy CP, Zager P, Kalantar-Zadeh K. Infrequent dialysis: a new paradigm for hemodialysis initiation. Semin Dial. 2013 Nov-Dec;26(6):720-7. doi: 10.1111/sdi.12133. Epub 2013 Sep 9.
- Background: PubMed 25616635Libetta C, Esposito P, Dal Canton A. Once-weekly hemodialysis: a single-center experience. Am J Kidney Dis. 2015 Feb;65(2):343. doi: 10.1053/j.ajkd.2014.07.034. No abstract available.
- Background: PubMed 24322579Bieber B, Qian J, Anand S, Yan Y, Chen N, Wang M, Wang M, Zuo L, Hou FF, Pisoni RL, Robinson BM, Ramirez SP. Two-times weekly hemodialysis in China: frequency, associated patient and treatment characteristics and Quality of Life in the China Dialysis Outcomes and Practice Patterns study. Nephrol Dial Transplant. 2014 Sep;29(9):1770-7. doi: 10.1093/ndt/gft472. Epub 2013 Dec 8.
- Background: PubMed 21819316Diao Z, Zhang D, Dai W, Ding J, Zhang A, Liu W. Preservation of residual renal function with limited water removal in hemodialysis patients. Ren Fail. 2011;33(9):875-7. doi: 10.3109/0886022X.2011.605535. Epub 2011 Aug 8.
- Background: PubMed 22612193Elamin S, Abu-Aisha H. Reaching target hemoglobin level and having a functioning arteriovenous fistula significantly improve one year survival in twice weekly hemodialysis. Arab J Nephrol Transplant. 2012 May;5(2):81-6.
- Individual participant dataSharing planned: Undecided
Related trials for Hemodialysis Complication
Active, not recruiting
Group Exercise Program Supported By Audiovisual Media During Hemodialysis
Chronic Kidney Failure, Hemodialysis
Not yet recruitingPhase 1/2
Bupropion for Fatigue in End-stage Kidney Disease Patients on Hemodialysis
End Stage Renal Disease, Fatigue
Active, not recruitingPhase 2
Management of Iron Deficiency Anemia in Hemodialysis Patients
Iron Deficiency Anemia (IDA), ESRD (End Stage Renal Disease)
Not yet recruitingObservational study
Malnutrition and Sarcopenia in Adults With Chronic Kidney Disease in Tunisia
Malnutrition, Sarcopenia
Not yet recruiting
Cycling During Dialysis: A Feasibility and Safety Study
Hemodialysis, Kidney Disease, End-Stage
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.
Mohamed E Elrggal, MD principal investigator
Alexandria University
Mohamed A Sobh, MD study chair
Mansoura University
Hussein A Sheashaa, MD study chair
Mansoura University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Individualized Incremental hemodialysis and Conventional thrice weekly hemodialysis in people with Hemodialysis Complication and ESRD, run by Alexandria University at 2 sites in Egypt.
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 2 inclusion and 8 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Survival rate after 24 months (time frame: 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 NCT03352271, which also lists 17 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 13 Jan 2021.