End Stage Renal DiseasePhase 2NCT00179140
The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
A Phase 2 study testing nutritional supplementation and exercise in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
Trial summary
The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- nutritional supplementation and exercise
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Feb 2006
- Phase
- Phase 2
- 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
- On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
- Adequately dialyzed (Kt/V > 1.4).
- Age > 18 years old.
- Properly functioning AV Graft
Who cannot join
- Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
- Pregnant women.
- Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
- Patients hospitalized within the last month prior to the study.
- Patients will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
About this study
The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.
- Conditions
- End Stage Renal Disease
- Being tested
- nutritional supplementation, exercise
- 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.
nutritional supplementationDrug
oral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat
exerciseBehavioural
either before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | control period |
| 2 | Active comparator | protein supplementation plus resistance exercise Receives: Drug: nutritional supplementation |
| 3 | Active comparator | protein supplementation only Receives: Drug: nutritional supplementation; Behavioral: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
increase in lean body mass
Measured: 13 months
Secondary outcomes (1)
improve physical functioning
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startNov 2002
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ikizler, Vanderbilt University
- Investigators
- Alp Ikizler, MD, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179140
- Sponsor's protocol ID
- 20064
- Other IDs
- R01DK045604
- Status last verified
- May 2015
- First submitted
- 13 Sep 2005
- Last updated
- 25 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
PubMed 35018639Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
PubMed 32390133
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Protein Supplementation and Resistance Exercise in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT00179140
- Acronym / sponsor ID
- 20064
- Conditions
- End Stage Renal Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- Nov 2002
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 15 Sep 2005 (estimated)
- 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 objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | –control period |
| 2 | Active comparator | Drug: nutritional supplementationprotein supplementation plus resistance exercise |
| 3 | Active comparator | Drug: nutritional supplementation, Behavioral: exerciseprotein supplementation only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
- Adequately dialyzed (Kt/V > 1.4).
- Age > 18 years old.
- Properly functioning AV Graft
Key exclusion criteria (5 listed)
- Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc.
- Pregnant women.
- Severe unstable underlying disease besides commonly associated with ESRD. Cardiac patients that are stable will be included.
- Patients hospitalized within the last month prior to the study.
- Patients will not perform the MRI if contraindication as determined using the VUMC MRI Procedure Screening Form (attached) or prior claustrophobic reaction in an MRI scanner.
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 |
|---|---|---|
| nutritional supplementationoral administration of protein supplement (Nepro) during hemodialysis; every other day, 3 days per week for 6 months; Nepro is a lactose-free formula that contains a total of 960 kilocalories: 132.8 kilocalories from protein, 412.8 kilocalories from carbohydrates, and 412.8 kilocalories from fat | Drug | 2, 3 |
| exerciseeither before or during hemodialysis, patients will perform a leg press exercise; every other day, 3 days per week, for 6 months | Behavioural | 3 |
Primary outcome
increase in lean body mass
Time frame: 13 months
1 secondary outcome
improve physical functioning
Time frame: 13 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 25 May 2015.
- Derived from this study: PubMed 35018639Bernier-Jean A, Beruni NA, Bondonno NP, Williams G, Teixeira-Pinto A, Craig JC, Wong G. Exercise training for adults undergoing maintenance dialysis. Cochrane Database Syst Rev. 2022 Jan 12;1(1):CD014653. doi: 10.1002/14651858.CD014653.
- Derived from this study: PubMed 32390133Mah JY, Choy SW, Roberts MA, Desai AM, Corken M, Gwini SM, McMahon LP. Oral protein-based supplements versus placebo or no treatment for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2020 May 11;5(5):CD012616. doi: 10.1002/14651858.CD012616.pub2.
Related trials for End Stage Renal Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
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.
Alp Ikizler, MD principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing nutritional supplementation and exercise in people with End Stage Renal Disease, run by Vanderbilt University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 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 25 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
increase in lean body mass (time frame: 13 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 NCT00179140, which also lists 2 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 25 May 2015.