Weight Loss in Obese Kidney Disease Patients After Bariat... | NCT02644928

Studies
Weight Loss in Obese Kidney Disease Patients After Bariatric Surgery

NCT02644928

Sponsor

Enrique Morales Ruiz, MD

Status

Completed

Last Update Posted

Aug 14, 2019Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Chronic Kidney Disease
Bariatric Surgery Candidate

Interventions

Not provided

Countries

Spain

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

Aug 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016Actual

Primary Completion Date

Aug 2019Actual

Completion Date

Aug 2019Actual

First Submitted Date

Dec 23, 2015

First Submission Date that Met QC Criteria

Dec 31, 2015

First Posted Date

Jan 1, 2016Estimated

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

Aug 13, 2019

Last Update Posted Date

Aug 14, 2019Actual

Name	Class
Hospital Universitario 12 de Octubre	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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

This study is designed as a prospective, single-center, longitudinal and analytical study on the effect of bariatric surgery in obese patients with chronic kidney disease (CKD).

Detailed Description

It is expected to enroll 22 obese subjects with chronic kidney disease (decrease in glomerular filtration and/or albuminuria/proteinuria). After the inclusion in the study patients will remain for six months with a reduced calorie diet until the day of bariatric surgery. Time monitoring of the patient after surgery is 24 months.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

12Actual

Measure	Description	Time Frame
Reduction of proteinuria/albuminuria in patients with obesity and nephropathy of any etiology treated with bariatric surgery	Reduction (measured as a percentage) of proteinuria/albuminuria in patients with obesity after bariatric surgery.	24 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-70 years (male or female).
BMI >35 kg/m2 who meet the following criteria:
1. GFR 30-60 ml/min and proteinuria>1g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
2. GFR >60 ml/min and proteinuria >(3.5) 2.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
Patients with BMI> 40 kg/m2 with a GFR> 30 ml/min and proteinuria >(1) 0.5 g/24 hours despite receiving maximally tolerated doses of blocking the renin-angiotensin system.
Patients who are able to understand the purpose and risks of the study, which has been fully informed and have finally given the written informed consent according to the ICH-GCP. Patients who can not read or write but who properly understand the verbal information provided by the investigator (or sub-investigator) the consent will be granted orally before their inclusion and an independent witness will signing the informed consent document.

Exclusion Criteria:

Subjects who are participating or have participated in another clinical trial and/or who are taking or have taken an experimental drug (not registered) in the last 28 days.
Patients with chronic renal replacement therapy (hemodialysis and/or peritoneal dialysis) and/or renal transplantation.
Patients with poorly controlled blood pressure (SBP> 170 mmHg or DBP> 110 mmHg).
Patients with a history of cardiovascular events (stroke, ischemic heart disease) in the past six months.
Patients treated with steroids or other immunosuppressants.
Patients with a history of renovascular disease, obstructive uropathy, autoimmune diseases, cancer, drug use.
Patients who are pregnant or lactating.
Patients who do not sign the informed consent.
A slight chance of compliance with visits scheduled in the protocol.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Obese subjects with renal pathology (decrease in glomerular filtration and/or albuminuria/proteinuria) who are candidates to bariatric surgery.

Sampling Method

Probability Sample

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