Outcomes of Renal Replacement in Mexico | NCT07474805

Studies
Outcomes of Renal Replacement in Mexico

NCT07474805

Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status

Not yet recruiting

Last Update Posted

Mar 16, 2026Actual

Enrollment

290Estimated

Phase

Not provided

Conditions

Chronic Kidney Disease - Stage V
Chronic Kidney Disease on Hemodialysis

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Apr 2026Estimated

Completion Date

Apr 2029Estimated

First Submitted Date

Mar 9, 2026

First Submission Date that Met QC Criteria

Mar 12, 2026

First Posted Date

Mar 16, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2026

Last Update Posted Date

Mar 16, 2026Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olynka Vega, Attending Physician, Department of Nephrology, Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranPrincipal Investigator

Lead Sponsor

Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

3 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

290Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CKD on RRT		Patients with chronic kidney disease undergoing renal replacement therapy (RRT) in Mexico

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
All-cause mortality	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 Outcomes

Measure	Description	Time Frame
Hospitalizations per patient-year	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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with chronic kidney disease undergoing hemodialysis or peritoneal dialysis in the units participating in the project

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Olynka Vega Vega, MD, MSc	Contact	+5215548039428		olynkavega@hotmail.com
Yazmin Alejandra Mercado Hernandez, MD	Contact	+5215520353821		yazale1992@hotmail.com

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided