Chronic Kidney Disease - Stage VORReMexNCT07474805
Outcomes of Renal Replacement in Mexico
An observational study of Chronic Kidney Disease - Stage V and Chronic Kidney Disease on Hemodialysis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
Trial summary
A descriptive, observational, prospective, multicenter study aimed at describing the main clinical outcomes of patients with chronic kidney disease receiving any form of renal replacement therapy in Mexico. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease - Stage V, Chronic Kidney Disease on Hemodialysis
- How many people
- 290 participants
- Where
- No sites listed yet
- Study dates
- Apr 2026to Apr 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic kidney disease undergoing hemodialysis or peritoneal dialysis in the units participating in the project
Who may be able to join
- Willingness to participate and provision of written informed consent
- Diagnosis of chronic kidney disease and treatment with hemodialysis or peritoneal dialysis for ≥3 months
- Availability of a medical record containing information on the study variables
- Receiving care at one of the participating centers
Who cannot join
- Life expectancy <3 months due to a cause unrelated to chronic kidney disease
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Outcomes Study of Mexican Patients With Chronic Kidney Disease on Renal Replacement Therapy
A descriptive, observational, prospective, multicenter study aimed at describing the main clinical outcomes of patients with chronic kidney disease receiving any form of renal replacement therapy in Mexico.
- Keywords
- Chronic kidney disease, Renal replacement therapy, Clinical outcomes
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CKD on RRT | Patients with chronic kidney disease undergoing renal replacement therapy (RRT) in Mexico |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality
The occurrence of death from any cause during the follow-up period, as documented in the patient's medical record
Measured: From enrollment in the study until death from any cause or end of follow-up, assessed up to 3 years.
Secondary outcomes (2)
Hospitalizations per patient-year
The number of hospitalizations recorded during the study follow-up, expressed per patient-year
Measured: From enrollment until the end of follow-up, assessed up to 3 years
Infection rate
The number of documented infection episodes during the follow-up period, as recorded in the medical records, expressed per patient-year.
Measured: From enrollment until the end of follow-up, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2029 (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 - Stage VStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 290 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Olynka Vega, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07474805
- Sponsor's protocol ID
- NMM-5533-25-28-1
- Acronym
- ORReMex
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It has not yet been determined whether individual participant data will be shared. Decisions regarding data sharing will be made after completion of the study and publication of the primary results, in accordance with institutional policies and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes Study of Mexican Patients With Chronic Kidney Disease on Renal Replacement Therapy
- ClinicalTrials.gov ID
- NCT07474805
- Acronym / sponsor ID
- ORReMex / NMM-5533-25-28-1
- Keywords
- Chronic kidney disease, Renal replacement therapy, Clinical outcomes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 16 Mar 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.
A descriptive, observational, prospective, multicenter study aimed at describing the main clinical outcomes of patients with chronic kidney disease receiving any form of renal replacement therapy in Mexico.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CKD on RRT | – | –Patients with chronic kidney disease undergoing renal replacement therapy (RRT) in Mexico |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic kidney disease undergoing hemodialysis or peritoneal dialysis in the units participating in the project
Key inclusion criteria (4 listed)
- Willingness to participate and provision of written informed consent
- Diagnosis of chronic kidney disease and treatment with hemodialysis or peritoneal dialysis for ≥3 months
- Availability of a medical record containing information on the study variables
- Receiving care at one of the participating centers
Key exclusion criteria (1 listed)
- Life expectancy <3 months due to a cause unrelated to chronic kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
All-cause mortality
Time frame: From enrollment in the study until death from any cause or end of follow-up, assessed up to 3 years.
The occurrence of death from any cause during the follow-up period, as documented in the patient's medical record
2 secondary outcomes
Hospitalizations per patient-year
Time frame: From enrollment until the end of follow-up, assessed up to 3 years
Infection rate
Time frame: From enrollment until the end of follow-up, assessed up to 3 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 16 Mar 2026.
- Individual participant dataSharing planned: Undecided. It has not yet been determined whether individual participant data will be shared. Decisions regarding data sharing will be made after completion of the study and publication of the primary results, in accordance with institutional policies and applicable regulations.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease - Stage V and Chronic Kidney Disease on Hemodialysis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran.
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 1 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 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Olynka Vega Vega, MD, MSc (+5215548039428, olynkavega@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
All-cause mortality (time frame: From enrollment in the study until death from any cause or end of follow-up, assessed up to 3 years.). 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 16 Mar 2026.