- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474805
Outcomes of Renal Replacement in Mexico (ORReMex)
March 12, 2026 updated by: Olynka Vega, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
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.
Study Overview
Status
Not yet recruiting
Study Type
Observational
Enrollment (Estimated)
290
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Olynka Vega Vega, MD, MSc
- Phone Number: +5215548039428
- Email: olynkavega@hotmail.com
Study Contact Backup
- Name: Yazmin Alejandra Mercado Hernandez, MD
- Phone Number: +5215520353821
- Email: yazale1992@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with chronic kidney disease undergoing hemodialysis or peritoneal dialysis in the units participating in the project
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Life expectancy <3 months due to a cause unrelated to chronic kidney disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
CKD on RRT
Patients with chronic kidney disease undergoing renal replacement therapy (RRT) in Mexico
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
From enrollment in the study until death from any cause or end of follow-up, assessed up to 3 years.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hospitalizations per patient-year
Time Frame: From enrollment until the end of follow-up, assessed up to 3 years
|
The number of hospitalizations recorded during the study follow-up, expressed per patient-year
|
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
|
The number of documented infection episodes during the follow-up period, as recorded in the medical records, expressed per patient-year.
|
From enrollment until the end of follow-up, assessed up to 3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
April 1, 2026
Primary Completion (Estimated)
April 1, 2026
Study Completion (Estimated)
April 1, 2029
Study Registration Dates
First Submitted
March 9, 2026
First Submitted That Met QC Criteria
March 12, 2026
First Posted (Actual)
March 16, 2026
Study Record Updates
Last Update Posted (Actual)
March 16, 2026
Last Update Submitted That Met QC Criteria
March 12, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Male Urogenital Diseases
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Pathological Conditions, Signs and Symptoms
- Renal Insufficiency, Chronic
Other Study ID Numbers
- NMM-5533-25-28-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
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.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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