Chronic Kidney Disease Clinical Trial
Official title:
Effects of Weight Loss on Renal Function in Obese Patients With Chronic Kidney Disease Undergoing Bariatric Surgery
NCT number | NCT02644928 |
Other study ID # | HDOC-BAROBE-2015-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 2016 |
Est. completion date | August 2019 |
Verified date | August 2019 |
Source | Hospital Universitario 12 de Octubre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 12 |
Est. completion date | August 2019 |
Est. primary completion date | August 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario 12 de Octubre | Madrid |
Lead Sponsor | Collaborator |
---|---|
Enrique Morales Ruiz, MD | Hospital Universitario 12 de Octubre |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
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