Dialysis PatientsPROSEDNCT07237997
Protein Supplementation During Dialysis (PROSED)
A study testing High Protein Diet/Modular protein supplements will be used in people with Dialysis Patients and Dialysis, run by University of Nottingham at 1 site in United Kingdom.
Trial summary
When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dialysis Patients, Dialysis, Protein Energy Wasting
- What is being tested?
- High Protein Diet/Modular protein supplements will be used
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Jan 2026to 30 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years (no upper age limit)
- Patients receiving maintenance dialysis for ≥ three months
- Ability to provide informed consent
Who cannot join
- Anticipated live donor kidney transplant and/or kidney recovery within the period of sample collection.
- Anticipated change of dialysis modality within the period of sample collection
- Severe malnutrition based on either:
- Renal 7-point Subjective Global Assessment (SGA) scores of 1-2
- Global Leadership Initiative Malnutrition (GLIM) Stage 2
- Protein-losing enteropathy.
Show all 18Show fewer
- Persistent nephrotic syndrome with >3g/day urinary protein loss.
- Active wounds or burns contributing to protein losses as judged by the investigator.
- Current active acute inflammatory illness (likely to have catabolic effect in the opinion of the investigator).
- Current malignancy based on recent (<12 months) diagnosis and/or active treatment for malignancy and/or planned treatment for malignancy, excluding non-melanoma skin cancers.
- Pregnancy (current or planned within duration of study) or breast feeding.
- People with swallowing difficulties precluding safe ingestion (International Dysphagia Diet Standardization Initiative (IDDSI) level 0 thin fluid).
- People receiving intradialytic parenteral nutrition or intra-peritoneal amino acids, or any other forms of artificial feeding
- People prescribed levodopa
- People who are receiving chronic glucocorticoid therapy (>10mg day prednisolone or equivalent for >7 days within preceding 90 days).
- People who are consuming a protein dietary intake above 1.5g protein/kg/body weight.
- People who, in the opinion of the investigator, will be unable to comply with study protocol requirements.
- People who are vegan or other religious based dietary restrictions which would prevent them taking the supplement.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Matthew Hall, MA, MBBChir, MD, FRCP contact
United Kingdom1 site
Centre for Kidney Research and Innovation (CKRI), Academic Unit for Translational Medical Sciences School of Medicine (Royal Derby Hospital Campus)
Nottingham, NG7 2QL
Bruno Mafrici, MSc, BSc, 0044 +115 9691169 ext. 77139, bruno.mafrici2@nottingham.ac.uk
Bruno Mafrici, BSC, MSc
About this study
Official title: Re-examining Nutrition in Dialysis Patients: Nutritional Losses and the Role of Supplementation (Part 2).
When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.
Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.
Read the detailed description
Malnutrition, specifically protein-energy wasting (PEW), is a major independent risk factor for poor quality of life and premature death in patients receiving dialysis.
Nutritional losses occur in patients on dialysis and have been documented over 40 years . Nutritional losses include nitrogen (amino acids, small peptides, proteins), trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (i.e. B vitamins and vitamin C). Dialysis membranes and modalities have changed over the past 40 years, and the investigators do not know if these nutritional losses (and their replacement) are of clinical significance to patients' clinical outcomes. In addition, research on this topic has focused on in-centre haemodialysis (ICHD), and, to a lesser extent, on peritoneal dialysis (PD). There are no studies reporting nutritional losses in patients receiving HD at home (HHD) and nocturnal HD (NHD) where different technologies and scheduling are often utilised. Nutritional losses could be different for different dialysis modalities. While there has been a lot of observational cohort data looking at different levels of protein intake, no long-term interventional studies have been conducted.
Funding was successfully obtained by Kidney Research UK to conduct two studies:
- Phase one, which is currently ongoing (IRAS 320440), aims to measure nutritional losses in people receiving maintenance dialysis, in different dialysis modalities.
- Phase two, this study (IRAS 343782), is a pragmatic pilot interventional study which will assess the impact of different protein intakes on patients' clinical outcomes in people on maintenance dialysis.
Dialysis techniques and modalities have changed significantly over the past 20 years. Yet current guidelines for protein provision are based on out-of-date data. Clinical guidelines for protein provision in ICHD and PD have not changed significantly in the past 20 years. There are no guidelines for HHD and NHD, as there is no evidence.
There are no main ethical or legal issues associated with this study. The primary aim of the study is to assess the association between hospitalisation rate and protein intake over a 2-year period.
Secondary objectives include associations between protein intake and mortality, cardiovascular outcomes, biophysical parameters, medication usage (such as erythropoietin, antibiotics, as well as other medication), infection rates, nutritional status (including anthropometry, body composition and functional markers of muscle mass) and quality of life indices
This study will be part two of a feasibility study where the investigators will assess whether protein supplementation impacts patient clinical outcomes. In part one, the investigators evaluated the protein losses in different dialysis modalities and measured nitrogen balance with stable isotopes (IRAS 320440).
The investigators know that there are protein losses via haemodialysis, peritoneal dialysis, home haemodialysis and nocturnal haemodialysis.
Participants will have a detailed nutritional assessment (including measurement of body composition), and their protein intake will be estimated at regular intervals for 2 years.
There are logistical issues in measuring nutritional status at each patient's home and these will be addressed by liaising with the home therapy team and coinciding nutritional assessment with patients' hospital visit as part of their standard care. Furthermore, patients will be asked to collect 24-hour urine collections (if they pass urine) at regular intervals. No additional blood samples will be needed (in addition to those required for standard care). These issues were discussed with our local team as well as by the patient representative group from Kidney Research UK, who acknowledged that this study is unlikely to carry a significant burden to participants.
There is no conflict of interest with this study.
Our research will fully engage with our patient and public involvement (PPI) group at the time of study design, during the research and upon completion. The investigators intend to schedule sample acquisition and study visits around standard therapies to minimise requirements for additional site visits. PPI input will be sought to confirm how the trial design can be optimised to minimise inconvenience to patients and maximise recruitment.
At the end of study, all participants will be informed of the overall findings with a written report in lay language, easy to understand.
- Conditions
- Dialysis Patients, Dialysis, Protein Energy Wasting, Protein Intake, High Protein Dietary Intake, Diet
- Being tested
- High Protein Diet/Modular protein supplements will be used
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein Diet/Modular protein supplements will be usedDietary supplement
High Protein Diet/Supplements 1.4g/kg/body weight/day
| Study group | Role | What they receive |
|---|---|---|
| Standard Protein Arm | No intervention | In the Standard Protein Arm, participants will aim to consume at least 1.0g of protein per kg of dry body weight. |
| High Protein Arm | Experimental | In the High Protein arm, participants will need to consume 1.4g of protein per kg of dry body weight a day and protein supplements will be used to achieve this (Renapro and Renapro shot) Receives: Dietary Supplement: High Protein Diet/Modular protein supplements will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.
Purpose
To measure the impact of different amounts of protein intake (protein in the diet) on clinical outcomes (including unplanned hospital admissions) in patients receiving the different dialysis modalities (ICHD, HHD, NHD and PD).
The investigators hypothesis is that a modality-specific and high-protein supplementation regimen reduces unplanned hospitalisation rate in patients receiving dialysis (ICHD, PD, HD, NHD) compared with those without supplementation.
Measured: 2 years
Secondary outcomes (1)
To assess association between protein intake and patients related outcomes measures.
To assess the correlation between protein intake and:
- the rate of mortality
- the incidence of cardiovascular events
- % of patients of specific medications (such as erythropoietin, antibiotics, as well as other medications)
- infection rates
- nutritional status , including body composition (measured via bioimpedence in kg of fat mass and kg fat free mass, calf circumference in cm), functional markers of muscle mass (measured via hand grip strength in kg and hand grip index)
- quality of life will be measure via a scales SF-36 and EuroQoL-5D
The following assessments will be performed using the following measurements:
Chronic Kidney Disease physical activity questionnaire Karnofsky score Subjective Global Assessment Global Leadership Initiative malnutrition tool Clinical Frailty score Malnutrition Inflammation score Sarcopenia -F tool
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2025
- Study start5 Jan 2026 (estimated)
- Primary completion30 Oct 2028 (estimated)
- Study completion30 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Dialysis PatientsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is an interventional pilot study of protein supplementation to test the hypothesis that a higher dietary protein intake is associated with a reduced unplanned hospitalisation admission rate over 2 years. The investigators will aim to recruit 114 participants with randomisation stratified across dialysis modalities (ICHD, CAPD, APD, HHD, NHD). Recruitment proportions will align with current dialysis populations at the study units - i.e., approximately 10-15% CAPD, 10-15% APD, 5-10% HHD, 3-5% NHD and 60-70% ICHD. Description of the intervention Once consented, participants will be randomly assigned to a high-protein group or usual care. Higher and usual protein intake targets, referred as individualised protein supplementation regimen, will be set within the limits of previously published mortality data Higher protein intake will aim to achieve 1.4g protein per kg of dry body weight per day usual protein intake will aim to achieve at least 1.0g protein per kg of dry body weight
- Masking
- None (open label)
- Enrolment
- 114 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University Hospitals of Derby and Burton NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Nicholas Selby, BMedSci BMBS DM, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07237997
- Sponsor's protocol ID
- 25032
- Other IDs
- SG_AHPF_001_20221129
- Acronym
- PROSED
- Status last verified
- Jul 2025
- First submitted
- 18 Jul 2025
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: If there is a need to share the IPD based on the findings of this study, a table will be included with the relevant data
Publications
Sahathevan S, Khor BH, Ng HM, Gafor AHA, Mat Daud ZA, Mafra D, Karupaiah T. Understanding Development of Malnutrition in Hemodialysis Patients: A Narrative Review. Nutrients. 2020 Oct 15;12(10):3147. doi: 10.3390/nu12103147.
PubMed 33076282Zazzeroni L, Pasquinelli G, Nanni E, Cremonini V, Rubbi I. Comparison of Quality of Life in Patients Undergoing Hemodialysis and Peritoneal Dialysis: a Systematic Review and Meta-Analysis. Kidney Blood Press Res. 2017;42(4):717-727. doi: 10.1159/000484115. Epub 2017 Oct 19.
PubMed 29049991Mafrici B, Armstrong-Brown V. Protein-energy wasting and nutritional requirements in dialysis. Journal Kidney Care 2017 2 (2), https://doi.org/10.12968/jokc.2017.2.2.
Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.
PubMed 31851983Viramontes-Horner D, Pittman Z, Selby NM, Taal MW. Impact of malnutrition on health-related quality of life in persons receiving dialysis: a prospective study. Br J Nutr. 2022 Jun 14;127(11):1647-1655. doi: 10.1017/S000711452100249X. Epub 2021 Jul 5.
PubMed 34218825Kittiskulnam P, Chuengsaman P, Kanjanabuch T, Katesomboon S, Tungsanga S, Tiskajornsiri K, Praditpornsilpa K, Eiam-Ong S. Protein-Energy Wasting and Mortality Risk Prediction Among Peritoneal Dialysis Patients. J Ren Nutr. 2021 Nov;31(6):679-686. doi: 10.1053/j.jrn.2020.11.007. Epub 2021 Feb 25.
PubMed 33642190Sabatino A, Regolisti G, Karupaiah T, Sahathevan S, Sadu Singh BK, Khor BH, Salhab N, Karavetian M, Cupisti A, Fiaccadori E. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr. 2017 Jun;36(3):663-671. doi: 10.1016/j.clnu.2016.06.007. Epub 2016 Jun 18.
PubMed 27371993
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Re-examining Nutrition in Dialysis Patients: Nutritional Losses and the Role of Supplementation (Part 2).
- ClinicalTrials.gov ID
- NCT07237997
- Acronym / sponsor ID
- PROSED / 25032
- Conditions
- Dialysis Patients, Dialysis, Protein Energy Wasting, Protein Intake, High Protein Dietary Intake, Diet
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 114 participants (estimated)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Collaborators
- Nottingham University Hospitals NHS Trust, University Hospitals of Derby and Burton NHS Foundation Trust
- Study start
- 5 Jan 2026 (estimated)
- Primary completion
- 30 Oct 2028 (estimated)
- Study completion
- 30 Oct 2029 (estimated)
- First posted
- 20 Nov 2025 (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.
When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.
Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.
Detailed description
Malnutrition, specifically protein-energy wasting (PEW), is a major independent risk factor for poor quality of life and premature death in patients receiving dialysis.
Nutritional losses occur in patients on dialysis and have been documented over 40 years . Nutritional losses include nitrogen (amino acids, small peptides, proteins), trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (i.e. B vitamins and vitamin C). Dialysis membranes and modalities have changed over the past 40 years, and the investigators do not know if these nutritional losses (and their replacement) are of clinical significance to patients' clinical outcomes. In addition, research on this topic has focused on in-centre haemodialysis (ICHD), and, to a lesser extent, on peritoneal dialysis (PD). There are no studies reporting nutritional losses in patients receiving HD at home (HHD) and nocturnal HD (NHD) where different technologies and scheduling are often utilised. Nutritional losses could be different for different dialysis modalities. While there has been a lot of observational cohort data looking at different levels of protein intake, no long-term interventional studies have been conducted.
Funding was successfully obtained by Kidney Research UK to conduct two studies:
- Phase one, which is currently ongoing (IRAS 320440), aims to measure nutritional losses in people receiving maintenance dialysis, in different dialysis modalities.
- Phase two, this study (IRAS 343782), is a pragmatic pilot interventional study which will assess the impact of different protein intakes on patients' clinical outcomes in people on maintenance dialysis.
Dialysis techniques and modalities have changed significantly over the past 20 years. Yet current guidelines for protein provision are based on out-of-date data. Clinical guidelines for protein provision in ICHD and PD have not changed significantly in the past 20 years. There are no guidelines for HHD and NHD, as there is no evidence.
There are no main ethical or legal issues associated with this study. The primary aim of the study is to assess the association between hospitalisation rate and protein intake over a 2-year period.
Secondary objectives include associations between protein intake and mortality, cardiovascular outcomes, biophysical parameters, medication usage (such as erythropoietin, antibiotics, as well as other medication), infection rates, nutritional status (including anthropometry, body composition and functional markers of muscle mass) and quality of life indices
This study will be part two of a feasibility study where the investigators will assess whether protein supplementation impacts patient clinical outcomes. In part one, the investigators evaluated the protein losses in different dialysis modalities and measured nitrogen balance with stable isotopes (IRAS 320440).
The investigators know that there are protein losses via haemodialysis, peritoneal dialysis, home haemodialysis and nocturnal haemodialysis.
Participants will have a detailed nutritional assessment (including measurement of body composition), and their protein intake will be estimated at regular intervals for 2 years.
There are logistical issues in measuring nutritional status at each patient's home and these will be addressed by liaising with the home therapy team and coinciding nutritional assessment with patients' hospital visit as part of their standard care. Furthermore, patients will be asked to collect 24-hour urine collections (if they pass urine) at regular intervals. No additional blood samples will be needed (in addition to those required for standard care). These issues were discussed with our local team as well as by the patient representative group from Kidney Research UK, who acknowledged that this study is unlikely to carry a significant burden to participants.
There is no conflict of interest with this study.
Our research will fully engage with our patient and public involvement (PPI) group at the time of study design, during the research and upon completion. The investigators intend to schedule sample acquisition and study visits around standard therapies to minimise requirements for additional site visits. PPI input will be sought to confirm how the trial design can be optimised to minimise inconvenience to patients and maximise recruitment.
At the end of study, all participants will be informed of the overall findings with a written report in lay language, easy to understand.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is an interventional pilot study of protein supplementation to test the hypothesis that a higher dietary protein intake is associated with a reduced unplanned hospitalisation admission rate over 2 years. The investigators will aim to recruit 114 participants with randomisation stratified across dialysis modalities (ICHD, CAPD, APD, HHD, NHD). Recruitment proportions will align with current dialysis populations at the study units - i.e., approximately 10-15% CAPD, 10-15% APD, 5-10% HHD, 3-5% NHD and 60-70% ICHD. Description of the intervention Once consented, participants will be randomly assigned to a high-protein group or usual care. Higher and usual protein intake targets, referred as individualised protein supplementation regimen, will be set within the limits of previously published mortality data Higher protein intake will aim to achieve 1.4g protein per kg of dry body weight per day usual protein intake will aim to achieve at least 1.0g protein per kg of dry body weight
| Arm | Type | Receives |
|---|---|---|
| Standard Protein Arm | No intervention | –In the Standard Protein Arm, participants will aim to consume at least 1.0g of protein per kg of dry body weight. |
| High Protein Arm | Experimental | Dietary Supplement: High Protein Diet/Modular protein supplements will be usedIn the High Protein arm, participants will need to consume 1.4g of protein per kg of dry body weight a day and protein supplements will be used to achieve this (Renapro and Renapro shot) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years (no upper age limit)
- Patients receiving maintenance dialysis for ≥ three months
- Ability to provide informed consent
Key exclusion criteria (18 listed)
- Anticipated live donor kidney transplant and/or kidney recovery within the period of sample collection.
- Anticipated change of dialysis modality within the period of sample collection
- Severe malnutrition based on either:
- Protein-losing enteropathy.
- Persistent nephrotic syndrome with >3g/day urinary protein loss.
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 |
|---|---|---|
| High Protein Diet/Modular protein supplements will be usedHigh Protein Diet/Supplements 1.4g/kg/body weight/day | Dietary supplement | High Protein Arm |
Primary outcome
To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.
Time frame: 2 years
Purpose To measure the impact of different amounts of protein intake (protein in the diet) on clinical outcomes (including unplanned hospital admissions) in patients receiving the different dialysis modalities (ICHD, HHD, NHD and PD). The investigators hypothesis is that a modality-specific and high-protein supplementation regimen reduces unplanned hospitalisation rate in patients receiving dialysis (ICHD, PD, HD, NHD) compared with those without supplementation.
1 secondary outcome
To assess association between protein intake and patients related outcomes measures.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Background: PubMed 33076282Sahathevan S, Khor BH, Ng HM, Gafor AHA, Mat Daud ZA, Mafra D, Karupaiah T. Understanding Development of Malnutrition in Hemodialysis Patients: A Narrative Review. Nutrients. 2020 Oct 15;12(10):3147. doi: 10.3390/nu12103147.
- Background: PubMed 29049991Zazzeroni L, Pasquinelli G, Nanni E, Cremonini V, Rubbi I. Comparison of Quality of Life in Patients Undergoing Hemodialysis and Peritoneal Dialysis: a Systematic Review and Meta-Analysis. Kidney Blood Press Res. 2017;42(4):717-727. doi: 10.1159/000484115. Epub 2017 Oct 19.
- BackgroundMafrici B, Armstrong-Brown V. Protein-energy wasting and nutritional requirements in dialysis. Journal Kidney Care 2017 2 (2), https://doi.org/10.12968/jokc.2017.2.2.
- Background: PubMed 31851983Hanna RM, Ghobry L, Wassef O, Rhee CM, Kalantar-Zadeh K. A Practical Approach to Nutrition, Protein-Energy Wasting, Sarcopenia, and Cachexia in Patients with Chronic Kidney Disease. Blood Purif. 2020;49(1-2):202-211. doi: 10.1159/000504240. Epub 2019 Dec 18.
- Background: PubMed 34218825Viramontes-Horner D, Pittman Z, Selby NM, Taal MW. Impact of malnutrition on health-related quality of life in persons receiving dialysis: a prospective study. Br J Nutr. 2022 Jun 14;127(11):1647-1655. doi: 10.1017/S000711452100249X. Epub 2021 Jul 5.
- Background: PubMed 33642190Kittiskulnam P, Chuengsaman P, Kanjanabuch T, Katesomboon S, Tungsanga S, Tiskajornsiri K, Praditpornsilpa K, Eiam-Ong S. Protein-Energy Wasting and Mortality Risk Prediction Among Peritoneal Dialysis Patients. J Ren Nutr. 2021 Nov;31(6):679-686. doi: 10.1053/j.jrn.2020.11.007. Epub 2021 Feb 25.
- Background: PubMed 27371993Sabatino A, Regolisti G, Karupaiah T, Sahathevan S, Sadu Singh BK, Khor BH, Salhab N, Karavetian M, Cupisti A, Fiaccadori E. Protein-energy wasting and nutritional supplementation in patients with end-stage renal disease on hemodialysis. Clin Nutr. 2017 Jun;36(3):663-671. doi: 10.1016/j.clnu.2016.06.007. Epub 2016 Jun 18.
- Lay Summary of Research Project from Kidney Research UK: What is the impact of different types of dialysis on levels of protein?Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. If there is a need to share the IPD based on the findings of this study, a table will be included with the relevant data
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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.
Matthew Hall, MA, MBBChir, MD, FRCP contact
Nicholas Selby, BMedSci BMBS DM principal investigator
University of Nottingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Protein Diet/Modular protein supplements will be used in people with Dialysis Patients and Dialysis, run by University of Nottingham at 1 site in United Kingdom.
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 3 inclusion and 18 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: opening soon, as of the sponsor's last update on 20 Nov 2025. 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 Kingdom. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Mafrici, MSc, BSc (0044 +115 9691169 ext. 77139, bruno.mafrici2@nottingham.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify how protein intake and supplements influence patients' unplanned hospitalisation rate. (time frame: 2 years). 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 NCT07237997, which also lists 7 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 20 Nov 2025.