Chronic Kidney Disease 5DPhase 1/2NCT07666815
Intradialytic Exercise Combined With Creatine Monohydrate in Patients With Chronic Kidney Disease Undergoing Hemodialysis.
A Phase 1/2 study testing Group A with creatine monohydrate, Group C Intradialytic Exercise Program and Comparison group D Hemodialysis in people with Chronic Kidney Disease 5D, run by Pedro Julian Flores Moreno at 1 site in Mexico.
Trial summary
This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease 5D
- What is being tested?
- Group A with creatine monohydrate, Group C Intradialytic Exercise Program and Comparison group D Hemodialysis
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteMexico
- Study dates
- 2 Mar 2026to 7 Aug 2026
- Phase
- Phase 1/2
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- atients who are treated at the State Haemodialysis Centre.
- Patients who receive haemodialysis three times a week.
- Signature of informed consent.
- Patients over 18 years of age, both men and women.
- Patients who have been on haemodialysis for no more than two years.
Who cannot join
- Patients who have had a limb amputated.
- Patients who are in a state of anuria.
- Inability to perform muscular resistance or aerobic resistance exercises.
- Patients unable to perform physical exercise.
- HIV-positive patients. Elimination.
- Patients who voluntarily withdraw from the project.
Show all 9Show fewer
- Inability to perform physical exercise.
- Death.
- Adverse events related to creatine consumption.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site, 1 recruiting
- Recruiting
IMSS-Bienestar State Haemodialysis Centre
Colima, Coliima, 28048
Evalyn Ceballos Medica cirujana y partera, 3121078792, eveceballoss@gmail.com
Pedro Julian Flores Moreno, Doctor of Medical Sciences
About this study
Official title: Effect of an Intradialytic Physical Exercise Programme Supplemented With Creatine Monohydrate on Body Composition, Biochemical Parameters and Functionality in Patients With Stage 5 Chronic Kidney Disease Undergoing Haemodialysis: Phase II Double-blind Randomised Clinical Trial.
This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. The study will compare the independent and combined effects of these interventions over an 8-week period to determine their potential benefits in this patient population.
Read the detailed description
A double-blind, randomized clinical trial will be conducted in patients with chronic kidney disease undergoing maintenance hemodialysis. The study will evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity.
Participants will be allocated to one of four study groups: (1) standard hemodialysis care, (2) creatine monohydrate supplementation, (3) intradialytic exercise, and (4) creatine monohydrate supplementation combined with intradialytic exercise. The intervention period will last 8 weeks.
Body composition, biochemical parameters, and functional capacity will be assessed at baseline and after completion of the intervention period. Comparisons among study groups will be performed to determine the independent and combined effects of creatine monohydrate supplementation and intradialytic exercise.
The study is designed to generate evidence regarding the potential clinical benefits of incorporating structured exercise programs and creatine supplementation into the routine management of patients receiving maintenance hemodialysis. Findings may contribute to the development of strategies aimed at improving physical function, nutritional status, and overall health outcomes in this population.
- Conditions
- Chronic Kidney Disease 5D
- Being tested
- Group A with creatine monohydrate, Group B placebo, Group C Intradialytic Exercise Program, Comparison group D Hemodialysis
- Keywords
- Creatine, Hemodialysis, Functionality
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A with creatine monohydrateDrug
Participants will receive 5 g of creatine monohydrate diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, supplementation will be administered immediately after the dialysis session. On non-dialysis days, supplementation will be administered after a meal.
Group B placeboOther
Participants will receive 5 g of placebo diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, placebo will be administered immediately after the dialysis session. On non-dialysis days, placebo will be administered after a meal.
Group C Intradialytic Exercise ProgramBehavioural
Participants will perform a supervised intradialytic exercise program during hemodialysis sessions for 8 weeks. The program will include aerobic and resistance exercises performed three times per week according to the study protocol.
Comparison group D HemodialysisProcedure or surgery
Participants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | consists of hemodialysis, intradialytic exercise, and creatine monohydrate. Receives: Drug: Group A with creatine monohydrate |
| Group B | Placebo comparator | consists of hemodialysis, intradialytic exercise, and placebo. Receives: Other: Group B placebo |
| Group C | Active comparator | consists of hemodialysis and exercise. Receives: Behavioral: Group C Intradialytic Exercise Program |
| Group D | Sham comparator | consists of hemodialysis. Receives: Procedure: Comparison group D Hemodialysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grasping muscle strength
Measurement of results in kilograms
Measured: From baseline assessments through the end of the 8-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start2 Mar 2026
- Primary completion22 Jul 2026 (estimated)
- Study completion7 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease 5DStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Study divided into four groups: Group A consists of hemodialysis, intradialytic exercise, and creatine monohydrate. Group B consists of hemodialysis, intradialytic exercise, and placebo. Group C consists of hemodialysis and exercise. Group D consists of hemodialysis.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pedro Julian Flores Moreno
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Pedro Julian Flores Moreno, Universidad de Colima
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666815
- Sponsor's protocol ID
- CEI2026/01/CR/CL/SFD/205
- Status last verified
- May 2026
- First submitted
- 18 May 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In order to have access to these data, other researchers must be performing the same methodological design, so there is no point in sharing it with a different study design..
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Intradialytic Physical Exercise Programme Supplemented With Creatine Monohydrate on Body Composition, Biochemical Parameters and Functionality in Patients With Stage 5 Chronic Kidney Disease Undergoing Haemodialysis: Phase II Double-blind Randomised Clinical Trial.
- ClinicalTrials.gov ID
- NCT07666815
- Acronym / sponsor ID
- CEI2026/01/CR/CL/SFD/205
- Conditions
- Chronic Kidney Disease 5D
- Keywords
- Creatine, Hemodialysis, Functionality
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Pedro Julian Flores MorenoUniversity, hospital or other
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 22 Jul 2026 (estimated)
- Study completion
- 7 Aug 2026 (estimated)
- First posted
- 24 Jun 2026 (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.
This study aims to evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity in patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis. The study will compare the independent and combined effects of these interventions over an 8-week period to determine their potential benefits in this patient population.
Detailed description
A double-blind, randomized clinical trial will be conducted in patients with chronic kidney disease undergoing maintenance hemodialysis. The study will evaluate the effects of creatine monohydrate supplementation and an intradialytic exercise program on body composition, biochemical parameters, and functional capacity.
Participants will be allocated to one of four study groups: (1) standard hemodialysis care, (2) creatine monohydrate supplementation, (3) intradialytic exercise, and (4) creatine monohydrate supplementation combined with intradialytic exercise. The intervention period will last 8 weeks.
Body composition, biochemical parameters, and functional capacity will be assessed at baseline and after completion of the intervention period. Comparisons among study groups will be performed to determine the independent and combined effects of creatine monohydrate supplementation and intradialytic exercise.
The study is designed to generate evidence regarding the potential clinical benefits of incorporating structured exercise programs and creatine supplementation into the routine management of patients receiving maintenance hemodialysis. Findings may contribute to the development of strategies aimed at improving physical function, nutritional status, and overall health outcomes in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Study divided into four groups: Group A consists of hemodialysis, intradialytic exercise, and creatine monohydrate. Group B consists of hemodialysis, intradialytic exercise, and placebo. Group C consists of hemodialysis and exercise. Group D consists of hemodialysis.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Drug: Group A with creatine monohydrateconsists of hemodialysis, intradialytic exercise, and creatine monohydrate. |
| Group B | Placebo comparator | Other: Group B placeboconsists of hemodialysis, intradialytic exercise, and placebo. |
| Group C | Active comparator | Behavioral: Group C Intradialytic Exercise Programconsists of hemodialysis and exercise. |
| Group D | Sham comparator | Procedure: Comparison group D Hemodialysisconsists of hemodialysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- atients who are treated at the State Haemodialysis Centre.
Key exclusion criteria (9 listed)
- Patients who have had a limb amputated.
- Patients who are in a state of anuria.
- Inability to perform muscular resistance or aerobic resistance exercises.
- Patients unable to perform physical exercise.
- HIV-positive patients. Elimination.
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 |
|---|---|---|
| Group A with creatine monohydrateParticipants will receive 5 g of creatine monohydrate diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, supplementation will be administered immediately after the dialysis session. On non-dialysis days, supplementation will be administered after a meal. | Drug | Group A |
| Group B placeboParticipants will receive 5 g of placebo diluted in 100 mL of water daily for 8 weeks. On hemodialysis days, placebo will be administered immediately after the dialysis session. On non-dialysis days, placebo will be administered after a meal. | Other | Group B |
| Group C Intradialytic Exercise ProgramParticipants will perform a supervised intradialytic exercise program during hemodialysis sessions for 8 weeks. The program will include aerobic and resistance exercises performed three times per week according to the study protocol. | Behavioural | Group C |
| Comparison group D HemodialysisParticipants will continue receiving their prescribed maintenance hemodialysis treatment according to the standard clinical procedures of the dialysis center. | Procedure or surgery | Group D |
Primary outcome
Grasping muscle strength
Time frame: From baseline assessments through the end of the 8-week intervention
Measurement of results in kilograms
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 24 Jun 2026.
- Effect of Creatine Supplementation on Body Composition and Malnutrition-Inflammation Score in Hemodialysis Patients: An Exploratory 1-Year, Balanced, Double-Blind DesignLink provided by the sponsor.
- Oral creatine in hemodialysis patients increases physical functional capacity and muscle mass, an open label studyLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In order to have access to these data, other researchers must be performing the same methodological design, so there is no point in sharing it with a different study design..
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Group A with creatine monohydrate, Group C Intradialytic Exercise Program and Comparison group D Hemodialysis in people with Chronic Kidney Disease 5D, run by Pedro Julian Flores Moreno at 1 site in Mexico.
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 9 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 24 Jun 2026. 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 Mexico. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
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 Israel Pérez Palafox PALAFOX Master of Medical Sciences (+523151260402, iperez@ucol.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grasping muscle strength (time frame: From baseline assessments through the end of the 8-week intervention). 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 24 Jun 2026.