End Stage Renal DiseaseNCT04260412
The Effect of Combining Medium Cut Off Dialysis Membrane and Diet Modification on Reducing of Inflammation Response
A study testing medium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%) and Sodium propionate in people with End Stage Renal Disease and Haemodialysis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
Trial summary
The investigators purpose is to research the impact of the simultaneous use of a new dialysis membrane with higher permeability for medium and protein bound uraemic toxins (medium cut-off dialysis membrane Theranova®) combined with diet modification to reduce the level of inflammation in chronic dialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease, Haemodialysis, Diet, Healthy
- What is being tested?
- medium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%) and Sodium propionate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSlovenia
- Study dates
- 31 Aug 2020to 31 Oct 2022
- 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
- Patient on chronic hemodialysis or hemodiafiltration for at least 12 weeks;
- Age 18 years old or more;
- A functioning arteriovenous fistula or graft as a permanent dialysis vascular access;
- Being able to give an informed consent to participate in the survey
Who cannot join
- Planned kidney transplantation, transition to peritoneal dialysis or to another dialysis center within 12 weeks of the start of the study
- Acute febrile inless 4 weeks prior to study inclusion
- Active chronic inflammation (e.g., an active autoimmune disease or an open wound), chronic ongoing infection or cancer
- New cardiovascular or cerebrovascular event 4 weeks prior to study inclusion
- Clinically malnourishet patient and/or BMI below 19 kg/m2 and/or loss of more the 5% of body mass in the last 3 months
- Immunosuppressive treatment
Show all 14Show fewer
- Expected survival of less than 1 year
- Pregnancy or breast-feeding
- Indication for dietary supplements to increase calorie and/or protein intake
- Specific indication for carrying out hemodiafiltration instead of hemodialysis as per attending physician
- Serum albumin concentration <32 g/l after screening to enter the study
- Inability to follow the study diet or test procedures
- Rapid reduction of residual renal function in the period prior to entry into the study
- Intolerant of on-line haemodiafiltration (infusion intolerance)
Trial locations and contacts
1 site in 1 country.
Slovenia1 site, 1 recruiting
- Recruiting
University Medical Centre Ljubljana
Ljubljana, 1000
Jernej Pajek, MD, PhD, 0038615228124, jernej.pajek@mf.uni-lj.si
About this study
Official title: The Effect of Combining Medium Cut Off Polyarylethersulfone-polyvinylpyrrolidone Dialysis Membrane and Diet Modification on Reducing of Inflammation Response
The investigators purpose is to research the impact of the simultaneous use of a new dialysis membrane with higher permeability for medium and protein bound uraemic toxins (medium cut-off dialysis membrane Theranova®) combined with diet modification to reduce the level of inflammation in chronic dialysis patients. The investigators hypothesize that the use of a medium-cut off dialysis membrane and dietary modification work synergistically and cause a significant and clinically meaningful reduction in inflammation levels compared to on-line hemodiafiltration with a high-flux dialysis membrane.
Read the detailed description
The investigators will carry out a prospective interventional randomised study to compare achieved serum concentrations of selected protein bound uremic toxins by dialysis with a medium cut-off membrane (Theranova, Baxter AG, USA) and online hemodiafiltration with a standard "high-flux" dialysis membrane. In the second phase, both dialysis purification methods will be supplemented by a change in the diet with increase of the daily intake of dietary fiber to 30g and addition of a short-chain fatty acid propionate in the dose of 1 g daily.
The main outcome of the study is the serum concentration of Interleukin-6. Secondary outcome is the serum concentration of interleukin-10, serum amyloid A, High-sensitivity C-reactive protein, total leukocyte count and plasma concentration of bacterial 16s rDNA. Serum albumin concentration and lean body weight of patients represent safety outcomes for this study.
This investigator-initiated research project has been entirely planned and will be conducted by the clinical researchers in a tertiary hospital University Medical Center Ljubljana.
The study will include 50 chronic prevalent stable dialysis patients in the following periods:
- 2 weeks of wash-in period with standard bicarbonate haemodialysis and standard high-flux dialysis membrane,
- then the patients will be randomized in a 1:1 ratio to either one of the two study arms:
- (interventional study arm) 4 weeks of dialysis with medium cut-off (Theranova) membrane (first phase), then dialysis for 4 weeks with the same membrane and increased fiber intake (second phase),
- (control study arm) 4 weeks of dialysis with a high-flux membrane using on-line haemodiafiltration (first phase) and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake (second phase),
- finally, all patients will undergo a 4 week wash-out period with a standard bicarbonate haemodialysis using standard high-flux dialysis membrane identical to wash-in period.
Measurement of the study end-points will be carried out at the end of 2-week wash-in period, each 4-week period and at the end of 4 week wash-out period.
- Being tested
- medium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%), Sodium propionate
- 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.
medium cut-off (MCO) dialysis membraneDevice
Also called Theranova dialysis membrane (Baxter AG)
Medium cut-off dialysis (MCO) membrane is a dialysis membrane with a higher molecular weight retention onset and similar cut-off as standard high-flux dialysis membranes. It is capable of providing increased clearance of medium sized uremic toxins and some plasma proteins (cytokines, inflammatory mediators).
Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%)Dietary supplement
Also called Kolon3Aktiv (Topnatur s.r.o., Czech republic)
Dietary fiber (Psyllium 69% and Inulin 30% mixture) added to the meals in the dose of 5g BID for 4 weeks in the second phase of the study.
Sodium propionateDietary supplement
Sodium propionate (a short-chain fatty acid) added to the meals in the dose of 500 mg BID in the second phase in the study.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm - MCO dialysis membrane | Experimental | 4 weeks of dialysis with MCO membrane, then dialysis for 4 weeks with MCO membrane and increased fiber intake Receives: Device: medium cut-off (MCO) dialysis membrane; Dietary Supplement: Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%); Dietary Supplement: Sodium propionate |
| Control arm - high-flux membrane haemodiafiltration | Active comparator | 4 weeks of high-flux membrane haemodiafiltration and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake Receives: Dietary Supplement: Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%); Dietary Supplement: Sodium propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum concentration of inflammatory mediator interleukin-6 (IL-6).
Blood for the laboratory measurements of serum total interleukin-6 concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
Measured: At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).
Secondary outcomes (1)
Serum concentration of inflammatory mediator High-sensitivity C-reactive protein (hs-CRP).
Blood for the laboratory measurements of serum total hs-CRP concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
Measured: At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start31 Aug 2020
- Primary completion30 Aug 2022 (estimated)
- Study completion31 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- More trials run by University Medical Centre LjubljanaThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, randomized, interventional, two parallel arm study.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Ljubljana
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ljubljana
- Responsible party
- Principal investigator, Jernej Pajek, University Medical Centre Ljubljana
- Investigators
- Jernej Pajek, MD, PhD, Study chair, Nephrology department, University Medical Centre Ljubljana, Slovenia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260412
- Sponsor's protocol ID
- RIIDINFLAMMATION
- Status last verified
- May 2022
- First submitted
- 5 Feb 2020
- Last updated
- 18 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Plan to share IPD that underline results published in the manuscripts reporting study results.
Publications
Dobre M, Meyer TW, Hostetter TH. Searching for uremic toxins. Clin J Am Soc Nephrol. 2013 Feb;8(2):322-7. doi: 10.2215/CJN.04260412. Epub 2012 Sep 27.
PubMed 23024165Depner TA. Uremic toxicity: urea and beyond. Semin Dial. 2001 Jul-Aug;14(4):246-51. doi: 10.1046/j.1525-139x.2001.00072.x.
PubMed 11489197Mostovaya IM, Blankestijn PJ, Bots ML, Covic A, Davenport A, Grooteman MP, Hegbrant J, Locatelli F, Vanholder R, Nube MJ; EUDIAL1 - an official ERA-EDTA Working Group. Clinical evidence on hemodiafiltration: a systematic review and a meta-analysis. Semin Dial. 2014 Mar;27(2):119-27. doi: 10.1111/sdi.12200.
PubMed 24738146Wang AY, Ninomiya T, Al-Kahwa A, Perkovic V, Gallagher MP, Hawley C, Jardine MJ. Effect of hemodiafiltration or hemofiltration compared with hemodialysis on mortality and cardiovascular disease in chronic kidney failure: a systematic review and meta-analysis of randomized trials. Am J Kidney Dis. 2014 Jun;63(6):968-78. doi: 10.1053/j.ajkd.2014.01.435. Epub 2014 Mar 28.
PubMed 24685515Zweigart C, Boschetti-de-Fierro A, Hulko M, Nilsson LG, Beck W, Storr M, Krause B. Medium cut-off membranes - closer to the natural kidney removal function. Int J Artif Organs. 2017 Jul 5;40(7):328-334. doi: 10.5301/ijao.5000603. Epub 2017 May 26. No abstract available.
PubMed 28574113Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
PubMed 28085888Eloot S, Van Biesen W, Glorieux G, Neirynck N, Dhondt A, Vanholder R. Does the adequacy parameter Kt/V(urea) reflect uremic toxin concentrations in hemodialysis patients? PLoS One. 2013 Nov 13;8(11):e76838. doi: 10.1371/journal.pone.0076838. eCollection 2013.
PubMed 24236005Montemurno E, Cosola C, Dalfino G, Daidone G, De Angelis M, Gobbetti M, Gesualdo L. What would you like to eat, Mr CKD Microbiota? A Mediterranean Diet, please! Kidney Blood Press Res. 2014;39(2-3):114-23. doi: 10.1159/000355785. Epub 2014 Jul 29.
PubMed 25117687Sirich TL. Dietary protein and fiber in end stage renal disease. Semin Dial. 2015 Jan-Feb;28(1):75-80. doi: 10.1111/sdi.12315. Epub 2014 Oct 16.
PubMed 25319504Claro LM, Moreno-Amaral AN, Gadotti AC, Dolenga CJ, Nakao LS, Azevedo MLV, de Noronha L, Olandoski M, de Moraes TP, Stinghen AEM, Pecoits-Filho R. The Impact of Uremic Toxicity Induced Inflammatory Response on the Cardiovascular Burden in Chronic Kidney Disease. Toxins (Basel). 2018 Sep 23;10(10):384. doi: 10.3390/toxins10100384.
PubMed 30249039Barrajon-Catalan E, Herranz-Lopez M, Joven J, Segura-Carretero A, Alonso-Villaverde C, Menendez JA, Micol V. Molecular promiscuity of plant polyphenols in the management of age-related diseases: far beyond their antioxidant properties. Adv Exp Med Biol. 2014;824:141-59. doi: 10.1007/978-3-319-07320-0_11.
PubMed 25038998Moe SM, Zidehsarai MP, Chambers MA, Jackman LA, Radcliffe JS, Trevino LL, Donahue SE, Asplin JR. Vegetarian compared with meat dietary protein source and phosphorus homeostasis in chronic kidney disease. Clin J Am Soc Nephrol. 2011 Feb;6(2):257-64. doi: 10.2215/CJN.05040610. Epub 2010 Dec 23.
PubMed 21183586Marzocco S, Fazeli G, Di Micco L, Autore G, Adesso S, Dal Piaz F, Heidland A, Di Iorio B. Supplementation of Short-Chain Fatty Acid, Sodium Propionate, in Patients on Maintenance Hemodialysis: Beneficial Effects on Inflammatory Parameters and Gut-Derived Uremic Toxins, A Pilot Study (PLAN Study). J Clin Med. 2018 Sep 30;7(10):315. doi: 10.3390/jcm7100315.
PubMed 30274359Kirsch AH, Lyko R, Nilsson LG, Beck W, Amdahl M, Lechner P, Schneider A, Wanner C, Rosenkranz AR, Krieter DH. Performance of hemodialysis with novel medium cut-off dialyzers. Nephrol Dial Transplant. 2017 Jan 1;32(1):165-172. doi: 10.1093/ndt/gfw310.
PubMed 27587605Krishnasamy R, Hawley CM, Jardine MJ, Roberts MA, Cho YJ, Wong MG, Heath A, Nelson CL, Sen S, Mount PF, Pascoe EM, Darssan D, Vergara LA, Paul-Brent PA, Toussaint ND, Johnson DW, Hutchison CA. Design and methods of the REMOVAL-HD study: a tRial Evaluating Mid cut-Off Value membrane clearance of Albumin and Light chains in HaemoDialysis patients. BMC Nephrol. 2018 Apr 17;19(1):89. doi: 10.1186/s12882-018-0883-8.
PubMed 29665795
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Combining Medium Cut Off Polyarylethersulfone-polyvinylpyrrolidone Dialysis Membrane and Diet Modification on Reducing of Inflammation Response
- ClinicalTrials.gov ID
- NCT04260412
- Acronym / sponsor ID
- RIIDINFLAMMATION
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Medical Centre LjubljanaUniversity, hospital or other
- Collaborators
- University of Ljubljana
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 30 Aug 2022 (estimated)
- Study completion
- 31 Oct 2022 (estimated)
- First posted
- 7 Feb 2020 (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.
The investigators purpose is to research the impact of the simultaneous use of a new dialysis membrane with higher permeability for medium and protein bound uraemic toxins (medium cut-off dialysis membrane Theranova®) combined with diet modification to reduce the level of inflammation in chronic dialysis patients. The investigators hypothesize that the use of a medium-cut off dialysis membrane and dietary modification work synergistically and cause a significant and clinically meaningful reduction in inflammation levels compared to on-line hemodiafiltration with a high-flux dialysis membrane.
Detailed description
The investigators will carry out a prospective interventional randomised study to compare achieved serum concentrations of selected protein bound uremic toxins by dialysis with a medium cut-off membrane (Theranova, Baxter AG, USA) and online hemodiafiltration with a standard "high-flux" dialysis membrane. In the second phase, both dialysis purification methods will be supplemented by a change in the diet with increase of the daily intake of dietary fiber to 30g and addition of a short-chain fatty acid propionate in the dose of 1 g daily.
The main outcome of the study is the serum concentration of Interleukin-6. Secondary outcome is the serum concentration of interleukin-10, serum amyloid A, High-sensitivity C-reactive protein, total leukocyte count and plasma concentration of bacterial 16s rDNA. Serum albumin concentration and lean body weight of patients represent safety outcomes for this study.
This investigator-initiated research project has been entirely planned and will be conducted by the clinical researchers in a tertiary hospital University Medical Center Ljubljana.
The study will include 50 chronic prevalent stable dialysis patients in the following periods:
- 2 weeks of wash-in period with standard bicarbonate haemodialysis and standard high-flux dialysis membrane,
- then the patients will be randomized in a 1:1 ratio to either one of the two study arms:
- (interventional study arm) 4 weeks of dialysis with medium cut-off (Theranova) membrane (first phase), then dialysis for 4 weeks with the same membrane and increased fiber intake (second phase),
- (control study arm) 4 weeks of dialysis with a high-flux membrane using on-line haemodiafiltration (first phase) and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake (second phase),
- finally, all patients will undergo a 4 week wash-out period with a standard bicarbonate haemodialysis using standard high-flux dialysis membrane identical to wash-in period.
Measurement of the study end-points will be carried out at the end of 2-week wash-in period, each 4-week period and at the end of 4 week wash-out period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, randomized, interventional, two parallel arm study.
| Arm | Type | Receives |
|---|---|---|
| Interventional arm - MCO dialysis membrane | Experimental | Device: medium cut-off (MCO) dialysis membrane, Dietary Supplement: Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%), Dietary Supplement: Sodium propionate4 weeks of dialysis with MCO membrane, then dialysis for 4 weeks with MCO membrane and increased fiber intake |
| Control arm - high-flux membrane haemodiafiltration | Active comparator | Dietary Supplement: Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%), Dietary Supplement: Sodium propionate4 weeks of high-flux membrane haemodiafiltration and 4 weeks of high-flux membrane haemodiafiltration and increased fiber intake |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient on chronic hemodialysis or hemodiafiltration for at least 12 weeks;
- Age 18 years old or more;
- A functioning arteriovenous fistula or graft as a permanent dialysis vascular access;
- Being able to give an informed consent to participate in the survey
Key exclusion criteria (14 listed)
- Planned kidney transplantation, transition to peritoneal dialysis or to another dialysis center within 12 weeks of the start of the study
- Acute febrile inless 4 weeks prior to study inclusion
- Active chronic inflammation (e.g., an active autoimmune disease or an open wound), chronic ongoing infection or cancer
- New cardiovascular or cerebrovascular event 4 weeks prior to study inclusion
- Clinically malnourishet patient and/or BMI below 19 kg/m2 and/or loss of more the 5% of body mass in the last 3 months
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 |
|---|---|---|
| medium cut-off (MCO) dialysis membraneAlso: Theranova dialysis membrane (Baxter AG)Medium cut-off dialysis (MCO) membrane is a dialysis membrane with a higher molecular weight retention onset and similar cut-off as standard high-flux dialysis membranes. It is capable of providing increased clearance of medium sized uremic toxins and some plasma proteins (cytokines, inflammatory mediators). | Device | Interventional arm - MCO dialysis membrane |
| Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%)Also: Kolon3Aktiv (Topnatur s.r.o., Czech republic)Dietary fiber (Psyllium 69% and Inulin 30% mixture) added to the meals in the dose of 5g BID for 4 weeks in the second phase of the study. | Dietary supplement | Control arm - high-flux membrane haemodiafiltration, Interventional arm - MCO dialysis membrane |
| Sodium propionateSodium propionate (a short-chain fatty acid) added to the meals in the dose of 500 mg BID in the second phase in the study. | Dietary supplement | Control arm - high-flux membrane haemodiafiltration, Interventional arm - MCO dialysis membrane |
Primary outcome
Serum concentration of inflammatory mediator interleukin-6 (IL-6).
Time frame: At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).
Blood for the laboratory measurements of serum total interleukin-6 concentration will be taken from the arterial line before the start of midweek hemodialysis procedure.
1 secondary outcome
Serum concentration of inflammatory mediator High-sensitivity C-reactive protein (hs-CRP).
Time frame: At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2022.
- Background: PubMed 23024165Dobre M, Meyer TW, Hostetter TH. Searching for uremic toxins. Clin J Am Soc Nephrol. 2013 Feb;8(2):322-7. doi: 10.2215/CJN.04260412. Epub 2012 Sep 27.
- Background: PubMed 11489197Depner TA. Uremic toxicity: urea and beyond. Semin Dial. 2001 Jul-Aug;14(4):246-51. doi: 10.1046/j.1525-139x.2001.00072.x.
- Background: PubMed 24738146Mostovaya IM, Blankestijn PJ, Bots ML, Covic A, Davenport A, Grooteman MP, Hegbrant J, Locatelli F, Vanholder R, Nube MJ; EUDIAL1 - an official ERA-EDTA Working Group. Clinical evidence on hemodiafiltration: a systematic review and a meta-analysis. Semin Dial. 2014 Mar;27(2):119-27. doi: 10.1111/sdi.12200.
- Background: PubMed 24685515Wang AY, Ninomiya T, Al-Kahwa A, Perkovic V, Gallagher MP, Hawley C, Jardine MJ. Effect of hemodiafiltration or hemofiltration compared with hemodialysis on mortality and cardiovascular disease in chronic kidney failure: a systematic review and meta-analysis of randomized trials. Am J Kidney Dis. 2014 Jun;63(6):968-78. doi: 10.1053/j.ajkd.2014.01.435. Epub 2014 Mar 28.
- Background: PubMed 28574113Zweigart C, Boschetti-de-Fierro A, Hulko M, Nilsson LG, Beck W, Storr M, Krause B. Medium cut-off membranes - closer to the natural kidney removal function. Int J Artif Organs. 2017 Jul 5;40(7):328-334. doi: 10.5301/ijao.5000603. Epub 2017 May 26. No abstract available.
- Background: PubMed 28085888Zickler D, Schindler R, Willy K, Martus P, Pawlak M, Storr M, Hulko M, Boehler T, Glomb MA, Liehr K, Henning C, Templin M, Trojanowicz B, Ulrich C, Werner K, Fiedler R, Girndt M. Medium Cut-Off (MCO) Membranes Reduce Inflammation in Chronic Dialysis Patients-A Randomized Controlled Clinical Trial. PLoS One. 2017 Jan 13;12(1):e0169024. doi: 10.1371/journal.pone.0169024. eCollection 2017.
- Background: PubMed 24236005Eloot S, Van Biesen W, Glorieux G, Neirynck N, Dhondt A, Vanholder R. Does the adequacy parameter Kt/V(urea) reflect uremic toxin concentrations in hemodialysis patients? PLoS One. 2013 Nov 13;8(11):e76838. doi: 10.1371/journal.pone.0076838. eCollection 2013.
- Background: PubMed 25117687Montemurno E, Cosola C, Dalfino G, Daidone G, De Angelis M, Gobbetti M, Gesualdo L. What would you like to eat, Mr CKD Microbiota? A Mediterranean Diet, please! Kidney Blood Press Res. 2014;39(2-3):114-23. doi: 10.1159/000355785. Epub 2014 Jul 29.
- Background: PubMed 25319504Sirich TL. Dietary protein and fiber in end stage renal disease. Semin Dial. 2015 Jan-Feb;28(1):75-80. doi: 10.1111/sdi.12315. Epub 2014 Oct 16.
- Background: PubMed 30249039Claro LM, Moreno-Amaral AN, Gadotti AC, Dolenga CJ, Nakao LS, Azevedo MLV, de Noronha L, Olandoski M, de Moraes TP, Stinghen AEM, Pecoits-Filho R. The Impact of Uremic Toxicity Induced Inflammatory Response on the Cardiovascular Burden in Chronic Kidney Disease. Toxins (Basel). 2018 Sep 23;10(10):384. doi: 10.3390/toxins10100384.
- Background: PubMed 25038998Barrajon-Catalan E, Herranz-Lopez M, Joven J, Segura-Carretero A, Alonso-Villaverde C, Menendez JA, Micol V. Molecular promiscuity of plant polyphenols in the management of age-related diseases: far beyond their antioxidant properties. Adv Exp Med Biol. 2014;824:141-59. doi: 10.1007/978-3-319-07320-0_11.
- Background: PubMed 21183586Moe SM, Zidehsarai MP, Chambers MA, Jackman LA, Radcliffe JS, Trevino LL, Donahue SE, Asplin JR. Vegetarian compared with meat dietary protein source and phosphorus homeostasis in chronic kidney disease. Clin J Am Soc Nephrol. 2011 Feb;6(2):257-64. doi: 10.2215/CJN.05040610. Epub 2010 Dec 23.
- Individual participant dataSharing planned: Yes. Plan to share IPD that underline results published in the manuscripts reporting study results.
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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.
Jernej Pajek, MD, PhD study chair
Nephrology department, University Medical Centre Ljubljana, Slovenia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing medium cut-off (MCO) dialysis membrane, Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%) and Sodium propionate in people with End Stage Renal Disease and Haemodialysis, run by University Medical Centre Ljubljana at 1 site in Slovenia.
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 14 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: status not confirmed, as of the sponsor's last update on 18 May 2022. 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 Slovenia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jernej Pajek, MH, PhD (+38615228124, jernej.pajek@mf.uni-lj.si), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum concentration of inflammatory mediator interleukin-6 (IL-6). (time frame: At the end of wash-in period (basal sample-baseline), at the end of first phase (4 weeks after baseline), at the end of second phase (8 weeks after baseline), at the end of wash-out period (12 weeks after baseline).). 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 NCT04260412, which also lists 18 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 18 May 2022.