Effect of CPAP in the Worsening of Renal Function in Early Stages of Chronic Kidney Disease (CKD)

NCT03319888 | Unknown

• 1 other identifier: PI15/00137
• Study Type: interventional
• Target: 700
• Locations: 1 country
• Sites: 1

Brief Summary

Objectives: Evaluate the effect of CPAP to reduce the progression of chronic kidney disease or CKD (the decline of glomerular filtration rate is ≥ 30%) in patients with early-stage renal disease and sleep apnea syndrome (OSAS). Other objectives are; determine the prevalence of OSAS in patients with early-stage renal disease and evaluate the changes in inflamatories markers and endothelial damage, the state of KDIGO, cardiovascular events, mortality and cost-effectiveness analysis in CPAP group versus non-CPAP group patients. Methods: A prospective, multicentric, randomized and controlled study will be carried out for 3 years. Early-stage renal disease (G1-3 KDIGO) and OSAS patients will be included. The investigators will make a respiratory polygraphy to determinate OSAS (AHI ≥15/h) and after that, the investigators randomized patients in 2 groups; CPAP group and control group (non-CPAP treatment). Patients with AHI \<15/h (non-OSAS) will be the reference group and the half of these patients, randomly chosen, will be followed up at the end of the follow up. Statistic analysis: the investigators will analyze the differences in glomerular filtration rate before and after the treatment, comparing the percentage of patients with CKD progression for both groups. The investigators will use the chi square test with raw data and adjusted for confounding variables using intention to treat analysis with imputation of missing values.

Conditions

Chronic Kidney Insufficiency; Sleep Apnea

Keywords

CPAP, Chronic kidney disease, sleep apnea

Outcome Measures

Primary Outcomes (1)

• To test whether treatment with CPAP in patients with moderate to severe OSAS and CKD in stages KDIGO G1-3, reduces the progression of renal disease (30% drop in GF) after 2 years of followed up.

  Number of participants with chronic kidney disease (CKD) and obstructive sleep apnea syndrome (OSAS) with a 30% decline in estimated glomerular filtration rate (eGFR) using the CKD-EPI (CKD Epidemiology Collaboration) 2009 creatinine equation after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

  after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

Secondary Outcomes (12)

• To estimate the prevalence of OSAS in patients with CKD stages G1-3 KDIGO

  after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

• To test whether treatment with CPAP reduces the albumin / creatinine ratio in urine.

  after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

• To evaluate whether treatment with CPAP reduces serum Cystatin C

  after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

• To evaluate whether treatment with CPAP reduces inflammation-endothelial disfunction markers

  after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

• Evaluate whether treatment with CPAP reduces the progression of CKD to a different stage

  after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)

Study Arms (2)

cpap group

EXPERIMENTAL

CPAP treatment plus conservative treatment with lifestyle modifications.

Device: CPAP

control group

ACTIVE COMPARATOR

Conservative treatment with lifestyle modifications.

Other: conservative treatment

Interventions

CPAP DEVICE

continuous positive pressure in the airway

cpap group

conservative treatment OTHER

conservative treatment group with lifestyle modifications

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients referred to the outpatient nephrology department with a diagnosis of chronic kidney disease stages G1-3 KDIGO
• Older than18 years
• Habitual snoring or observed apneas
• Scale sleep sleepiness (Epworth Test) with 11 points or lower.

You may not qualify if:

• Very debilitating chronic or neoplastic disease
• Respiratory failure (PaO 2 \<55 mm Hg).
• Other symptoms of suspected sleep disorder different from OSAS.
• Patients unable to perform self-administered questionnaires.
• Patients with\> 50% of central apnea or Cheyne-Stokes.
• Patients who do not sign the informed consent.

Sponsors & Collaborators

• Sociedad Española de Neumología y Cirugía Torácica: lead

Study Sites (1)

Jaime Corral

Cáceres, 10003, Spain

RECRUITING

Related Publications (23)

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MeSH Terms

Conditions

Renal Insufficiency, Chronic; Sleep Apnea Syndromes; Microcephaly, Primary Autosomal Recessive, 6

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Jaime Corral, MD

CONTACT

+34-927256204; jcorral@separ.es

Juan F Masa, PHD

CONTACT

+34-927256204; fmasa@separ.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2016
• First Posted: October 24, 2017
• Study Start: November 20, 2017
• Primary Completion: November 20, 2019
• Study Completion: May 20, 2020
• Last Updated: March 6, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)