Ignite Creation Date:
2025-12-24 @ 5:51 PM
Ignite Modification Date:
2026-02-24 @ 8:51 AM
Study NCT ID:
NCT01872468
Status:
COMPLETED
Last Update Posted:
2015-04-13
First Post:
2013-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Structured Intervention to Reduce the Progression of Chronic Kidney (RENAP Study)
Sponsor:
Gerencia de Atención Primaria, Madrid
Organization:
Study Overview
Official Title:
Effectiveness of an Structured Intervention in Patients With Chronic Kidney Failure to Reduce the Progression of the Illness.
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RENAP
Brief Summary:
The propose of study is to study if an informative intervention and a structured follow-up carried out in health centres of primary care in patients with chronic kidney failure, stage 3, is more effective than the current follow-up in slowing the disease progression measured by the glomerular filtration rate.
Detailed Description:
Main objective: To study if an informative intervention and a structured follow-up carried out in health centres of primary care in patients with chronic kidney failure, stages 3, is more effective than the current follow-up in slowing the disease progression measured by the glomerular filtration rate .
Secondary objectives: Determining the effectiveness of the intervention to improve the blood pressure control of the patients with chronic kidney failure and to improve the degree of control of the glucose levels and glycosylated haemoglobin of the diabetic patients with chronic kidney failure.
Design: A clinical trial controlled with a random assignment by conglomerates with parallel groups.
Setting: Multi-centre study in Primary Care Health Centres(Madrid Health Service).
Subjects of the study: 540 patients over 18 years old, diagnosed of light-moderate chronic kidney failure that consent to participate.
Data collection: The variable of the main answer will be the creatinine clearance measured in ml/min. Demographic variables of morbidity and prognosis: clinical, analytical, anthropometrical, adherence to processing and consumption of medicines will be collected.
Intervention: Initial educational session based on the significant learning and quarterly follow-up in surgery of medicine and nursing for 2 years.
Analysis: By intention of treating. Descriptive statistics of each variable and statistical analytical univariate and multivariate (multiple linear regression) will be carried out. The explanatory variable in the analysis multivariate will be the intervention group.
Secondary objectives: Determining the effectiveness of the intervention to improve the blood pressure control of the patients with chronic kidney failure and to improve the degree of control of the glucose levels and glycosylated haemoglobin of the diabetic patients with chronic kidney failure.
Design: A clinical trial controlled with a random assignment by conglomerates with parallel groups.
Setting: Multi-centre study in Primary Care Health Centres(Madrid Health Service).
Subjects of the study: 540 patients over 18 years old, diagnosed of light-moderate chronic kidney failure that consent to participate.
Data collection: The variable of the main answer will be the creatinine clearance measured in ml/min. Demographic variables of morbidity and prognosis: clinical, analytical, anthropometrical, adherence to processing and consumption of medicines will be collected.
Intervention: Initial educational session based on the significant learning and quarterly follow-up in surgery of medicine and nursing for 2 years.
Analysis: By intention of treating. Descriptive statistics of each variable and statistical analytical univariate and multivariate (multiple linear regression) will be carried out. The explanatory variable in the analysis multivariate will be the intervention group.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: