Kidney FailureNCT06343727
A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
A study testing Egg white protein pudding and : Ensure Plus in people with Kidney Failure and Frailty, run by Seven Oaks Hospital Chronic Disease Innovation Centre at 2 sites in Canada.
Trial summary
The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are: To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Frailty, Kidney Disease, Chronic
- What is being tested?
- Egg white protein pudding and : Ensure Plus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Jul 2025to 1 Oct 2026
- 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
- Participant is willing and able to give informed consent for participation in the trial
- Male or female aged ≥18 years with CKD
- On chronic in-center hemodialysis for > 3 months
- Serum albumin <35 g/L
- No expected change in dialysis modality or relocation outside of Winnipeg during the intervention period (12 weeks)
Who cannot join
- Allergy to eggs
- History of renal transplant
- Serum albumin ≥ 35 g/L
- Bowel diseases
- Cancer
- Pregnancy
Show all 11Show fewer
- Receiving chemotherapy treatment
- Inability to consume treatment product
- Allergy to study treatment ingredients
- Planning on starting an exercise program during the duration of the trial
- Inability to obtain written informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
Seven Oaks General Hospital
Winnipeg, Manitoba, R2V 3M3
Navdeep Tangri, PhD, MD, 204 631-3834, ntangri@sogh.mb.ca
Rebecca Mollard, PhD, 204 631-3834, rmollard@sogh.mb.ca
- Recruiting
Health Science Centre
Winnipeg, Manitoba, R3A 1R9
Navdeep Tangri, PhD, 204-631-3834, ntangri@sogh.mb.ca
Rebecca Mollard, PhD, 204-631-3834, rmollard@sogh.mb.ca
About this study
The goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:
- To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.
- To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.
- To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.
- Conditions
- Kidney Failure, Frailty, Kidney Disease, Chronic
- Being tested
- Egg white protein pudding, : Ensure Plus
- Medical subject headings
- Renal Insufficiency, Frailty, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Egg white protein puddingDietary supplement
Will consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks
: Ensure PlusDietary supplement
Will consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Egg white protein pudding | Experimental | Participants will receive egg white pudding at the end of their dialysis treatments 3-days per week. Receives: Dietary Supplement: Egg white protein pudding |
| : Standard dietary supplement | Active comparator | Participants will receive Ensure Plus at the end of their dialysis treatments 3-days per week. Receives: Dietary Supplement: : Ensure Plus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eligibility to randomization ratio
A ratio of eligibility to randomization will be collected at 12 months using pre-specified red-yellow-green progression criteria to investigate egg pudding intervention feasibility. The trial will be considered feasible if ratio falls within green zone (>0.5). The outcome in the yellow zone (0.2-0.5) indicate that modifications to trial design may be necessary and in the red zone (<0.2) will suggest the trial is not feasible.
Measured: Measured at the end of 12 weeks.
Recruitment rate
Recruitment rate will be assessed as the number of new participants enrolled per site per month during active recruitment using the red-yellow-green progression criteria.
Green: ≥ 0.75 participants/site/month - Feasible; Yellow: 0.25 - <0.75 participants/site/month - Modification may be necessary; Red: < 0.25 participants /site/month - Not feasible
Measured: 12 months
Follow up rate
Follow-up rate (% of participant outcomes) will be calculated using the red-yellow-green progression criteria.
Green: > 90% - Feasible; Yellow: (75% - 90%) -Modifications may be necessary; Red: <75% -Not feasible.
Measured: Measured at the end of 12 weeks.
Adherence to Intervention
Adherence to egg white product intervention (% of dispensed egg white protein consumed) will be calculated using red-yellow-green progression criteria.
Green: > 75% - Feasible; Yellow: 50%-75% - Modifications may be necessary; Red: <50% - Not feasible
Measured: Measured at the end of12 weeks
Secondary outcomes (15)
Hand grip strength
Measuring the amount of static force that the hand can squeeze around a dynamometer. Measured in kilograms and pounds.
Measured: Measured at the end of 12 weeks.
Change in gait speed
Gait speed is measured by the predetermined distance/time to walk that distance (e.g., 5m/__sec)
Measured: Measured at the end of 12 weeks.
Five rep chair stand time
the amount of time it takes for a participant to get up out of a chair five times measured in seconds
Measured: Measured at the end of 12 weeks.
Tandem balance time
Measured in Seconds
Measured: Measured at the end of 12 weeks.
Serum albumin
Serum albumin is measured in grams per deciliter (g/dL)
Measured: Measured at the end of 12 weeks.
Serum bicarbonate
Serum bicarbonate concentration in milliequivalents per liter (mEq/L)
Measured: Measured at the end of 12 weeks.
Calcium
Total blood calcium concentration in mmol/L
Measured: Measured at the end of 12 weeks.
chloride
Total blood chloride concentration in mmol/L
Measured: Measured at the end of 12 weeks.
phosphorus
The total blood phosphorus concentration in mmol/L
Measured: Measured at the end of 12 weeks.
Potassium
The total blood potassium concentration in mmol/L
Measured: Measured at the end of 12 weeks.
Sodium
The total sodium concentration in mmol/L
Measured: Measured at the end of 12 weeks.
HbA1c
Total blood glucose concentration in mmol/L
Measured: Measured at the end of 12 weeks.
Dry Weight
Measured in kg
Measured: Measured at the end of 12 weeks
Height
Measured in cm
Measured: Measured at the end of 12 weeks
Pre-dialysis Blood pressure
Systolic and diastolic blood pressure measured in mmHg
Measured: Measured at the end of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start25 Jul 2025
- Primary completion11 Aug 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This trial is an open-label randomized controlled parallel arm feasibility trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seven Oaks Hospital Chronic Disease Innovation Centre
- Sponsor type
- Research network
- Collaborators
- University of Manitoba, Manitoba Egg Farmers
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343727
- Sponsor's protocol ID
- HS25870 (H2023:026)
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2024
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A High Protein Egg White Pudding for People With Kidney Failure (HiPE KF)
- ClinicalTrials.gov ID
- NCT06343727
- Acronym / sponsor ID
- HS25870 (H2023:026)
- Conditions
- Kidney Failure, Frailty, Kidney Disease, Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Seven Oaks Hospital Chronic Disease Innovation CentreResearch network
- Collaborators
- University of Manitoba, Manitoba Egg Farmers
- Study start
- 25 Jul 2025 (actual)
- Primary completion
- 11 Aug 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 3 Apr 2024 (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 goal of this clinical trial is to compare protein supplements in patients with kidney failure on dialysis. The main questions it aims to answer are:
- To determine whether the supplementation of egg white protein pudding in a population of individuals with kidney failure on dialysis is feasible.
- To determine whether egg white protein pudding supplementation improves serum albumin similar to other standard nutritional supplements.
- To determine the effects of the egg white protein pudding on frailty measures, dietary intakes and analytes in the blood. Participants will receive either the egg white pudding (experimental) or control (Ensure plus) at the end of their dialysis treatments 3-days per week for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- This trial is an open-label randomized controlled parallel arm feasibility trial
| Arm | Type | Receives |
|---|---|---|
| Egg white protein pudding | Experimental | Dietary Supplement: Egg white protein puddingParticipants will receive egg white pudding at the end of their dialysis treatments 3-days per week. |
| : Standard dietary supplement | Active comparator | Dietary Supplement: : Ensure PlusParticipants will receive Ensure Plus at the end of their dialysis treatments 3-days per week. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant is willing and able to give informed consent for participation in the trial
- Male or female aged ≥18 years with CKD
- On chronic in-center hemodialysis for > 3 months
- Serum albumin <35 g/L
- No expected change in dialysis modality or relocation outside of Winnipeg during the intervention period (12 weeks)
Key exclusion criteria (11 listed)
- Allergy to eggs
- History of renal transplant
- Serum albumin ≥ 35 g/L
- Bowel diseases
- Cancer
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 |
|---|---|---|
| Egg white protein puddingWill consume one egg white protein pudding at the end of their dialysis treatments 3-days per week for 12 weeks | Dietary supplement | Egg white protein pudding |
| : Ensure PlusWill consume one Ensure Plus at the end of their dialysis treatments 3-days per week for 12 weeks | Dietary supplement | : Standard dietary supplement |
Primary outcome
Eligibility to randomization ratio
Time frame: Measured at the end of 12 weeks.
A ratio of eligibility to randomization will be collected at 12 months using pre-specified red-yellow-green progression criteria to investigate egg pudding intervention feasibility. The trial will be considered feasible if ratio falls within green zone (>0.5). The outcome in the yellow zone (0.2-0.5) indicate that modifications to trial design may be necessary and in the red zone (<0.2) will suggest the trial is not feasible.
Recruitment rate
Time frame: 12 months
Recruitment rate will be assessed as the number of new participants enrolled per site per month during active recruitment using the red-yellow-green progression criteria. Green: ≥ 0.75 participants/site/month - Feasible; Yellow: 0.25 - <0.75 participants/site/month - Modification may be necessary; Red: < 0.25 participants /site/month - Not feasible
Follow up rate
Time frame: Measured at the end of 12 weeks.
Follow-up rate (% of participant outcomes) will be calculated using the red-yellow-green progression criteria. Green: > 90% - Feasible; Yellow: (75% - 90%) -Modifications may be necessary; Red: <75% -Not feasible.
Adherence to Intervention
Time frame: Measured at the end of12 weeks
Adherence to egg white product intervention (% of dispensed egg white protein consumed) will be calculated using red-yellow-green progression criteria. Green: > 75% - Feasible; Yellow: 50%-75% - Modifications may be necessary; Red: <50% - Not feasible
15 secondary outcomes
Hand grip strength
Time frame: Measured at the end of 12 weeks.
Change in gait speed
Time frame: Measured at the end of 12 weeks.
Five rep chair stand time
Time frame: Measured at the end of 12 weeks.
Tandem balance time
Time frame: Measured at the end of 12 weeks.
Serum albumin
Time frame: Measured at the end of 12 weeks.
Serum bicarbonate
Time frame: Measured at the end of 12 weeks.
Calcium
Time frame: Measured at the end of 12 weeks.
chloride
Time frame: Measured at the end of 12 weeks.
phosphorus
Time frame: Measured at the end of 12 weeks.
Potassium
Time frame: Measured at the end of 12 weeks.
Sodium
Time frame: Measured at the end of 12 weeks.
HbA1c
Time frame: Measured at the end of 12 weeks.
Dry Weight
Time frame: Measured at the end of 12 weeks
Height
Time frame: Measured at the end of 12 weeks
Pre-dialysis Blood pressure
Time frame: Measured at the end of 12 weeks
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 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Egg white protein pudding and : Ensure Plus in people with Kidney Failure and Frailty, run by Seven Oaks Hospital Chronic Disease Innovation Centre at 2 sites in Canada.
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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. 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 Canada. 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 Navdeep Tangri, MD, PhD (2046313834, ntangri@sogh.mb.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eligibility to randomization ratio (time frame: Measured at the end of 12 weeks.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2026.