- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07474805
Outcomes of Renal Replacement in Mexico (ORReMex)
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
Study Type
Enrollment (Estimated)
Contacts and Locations
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
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
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
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
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
Studies a U.S. FDA-regulated device product
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