Chronic Kidney InsufficiencyRenasNCT03319888

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

A study testing CPAP and conservative treatment in people with Chronic Kidney Insufficiency and Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Insufficiency, Sleep Apnea
What is being tested?: CPAP and conservative treatment
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 700 participants
Where: 1 siteSpain
Study dates: 20 Nov 2017to 20 May 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Jaime Corral, MD contact

+34-927256204

jcorral@separ.es

Juan F Masa, PHD contact

+34-927256204

fmasa@separ.es

Spain1 site, 1 recruiting

Jaime Corral
Cáceres, 10003
Jaime Corral, MD, 927256204, jcorral@separ.es
Recruiting

Other trials in Spain

About this study

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.

Read the detailed description

There is a bidirectional involvement between the chronic kidney disease (CKD) and sleep apnea syndrome (OSAS). The declining of renal function, the fluid overloading and the disturbance of ventilation control could cause sleep apneas. On the other hand, the nocturnal hypoxia in patients with OSAS has been associated with changes in the renin-angiotensin system and sympathetic nervous system and production of reactive oxygen species. These findings are relationed with the deterioration of kidney function.

Conditions: Chronic Kidney Insufficiency, Sleep Apnea
Being tested: CPAP, conservative treatment
Keywords: CPAP, Chronic kidney disease, sleep apnea
Medical subject headings: Renal Insufficiency, Chronic, Sleep Apnea Syndromes, Microcephaly, Primary Autosomal Recessive, 6

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CPAPDevice
continuous positive pressure in the airway
conservative treatmentOther
conservative treatment group with lifestyle modifications

Study groups in NCT03319888
Study group	Role	What they receive
cpap group	Experimental	CPAP treatment plus conservative treatment with lifestyle modifications. Receives: Device: CPAP
control group	Active comparator	Conservative treatment with lifestyle modifications. Receives: Other: conservative treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: 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
Number of participants with CKD and snoring and observed apneas with an apnea and hypoapnea index (AHI) ≥15/hour in home-based polysomnography.
Measured: 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.
Number of participants with CKD and OSAS with a decline in urine albumin to creatinine ratio.
Measured: 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
Number of participants with CKD and OSAS with a decline in serum cystatin C levels
Measured: 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
Number of participants with CKD and OSAS with a decline in inflammation-endothelial disfunction markers (interleukine-6, interleukine-8, reactive C protein, sedimentation rate, asymmetric dimethylaginine or ADMA, intercellular adhesion molecule 1 or ICAM-1, vascular adhesion protein 1 or VCAM 1, vascular endothelial growth factor or VEGF)
Measured: 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
number of participants with CKD and OSAS with a change to a higher CKD stage according to eGFR.
Measured: 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 wheather CPAP reduces the percentage of patients achieving replacement therapy
number of participants with CKD and OSAS who need renal replacement therapy (haemodialysis, peritoneal dialysis or renal transplantation)
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Evaluate wheather treatment with CPAP reduces the incidence of cardiovascular events
number of participants with CKD and OSAS who suffered a cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure, atrial fibrillation)
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Evaluate wheather treatment with CPAP reduces the mortality
number of participants with CKD and OSAS with CPAP treatment who died (all-cause mortality)
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Evaluation of the cost-effectiveness of treatment groups with and without CPAP
Cost-effectiveness of treatment groups conducting a cost-effectiveness study that allow us to estimate the incremental cost-effectiveness ratio (ICER) of CPAP treatment group compared to the conventional treatment group
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)
Compare the evolution of inflammation-endothelial disfunction markers in NO-OSAS group versus OSAS group
Number of participants with NO-OSAS versus OSAS who have a decline in inflammation-endothelial disfunction markers (interleukine-6, interleukine-8, reactive C protein, sedimentation rate, asymmetric dimethylaginine or ADMA, intercellular adhesion molecule 1 or ICAM-1, vascular adhesion protein 1 or VCAM 1, vascular endothelial growth factor or VEGF)
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)
Compare the worsening of the glomerular filtration in NO OSAS group versus OSAS group
number of participants with NO OSAS versus OSAS who have a worsening of the glomerular filtration.
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)
Compare the percentage of patients achieving renal replacement therapy in NO OSAS group versus OSAS group
number of participants who need renal replacement therapy in NO OSAS group versus OSAS group
Measured: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Nov 201720 May 2020

First posted24 Oct 2017
Study start20 Nov 2017
Primary completion20 Nov 2019 (estimated)
Study completion20 May 2020 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Chronic Kidney InsufficiencyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 700 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03319888
Sponsor's protocol ID: PI15/00137
Acronym: Renas
Status last verified: Oct 2017
First submitted: 23 Sep 2016
Last updated: 6 Mar 2018
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
PubMed 23727169
James MT, Hemmelgarn BR, Tonelli M. Early recognition and prevention of chronic kidney disease. Lancet. 2010 Apr 10;375(9722):1296-309. doi: 10.1016/S0140-6736(09)62004-3.
PubMed 20382326
Otero A, de Francisco A, Gayoso P, Garcia F; EPIRCE Study Group. Prevalence of chronic renal disease in Spain: results of the EPIRCE study. Nefrologia. 2010;30(1):78-86. doi: 10.3265/Nefrologia.pre2009.Dic.5732. Epub 2009 Dec 14.
PubMed 20038967
Lloberes P, Duran-Cantolla J, Martinez-Garcia MA, Marin JM, Ferrer A, Corral J, Masa JF, Parra O, Alonso-Alvarez ML, Teran-Santos J. Diagnosis and treatment of sleep apnea-hypopnea syndrome. Spanish Society of Pulmonology and Thoracic Surgery. Arch Bronconeumol. 2011 Mar;47(3):143-56. doi: 10.1016/j.arbres.2011.01.001. No abstract available. English, Spanish.
PubMed 21398016
Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
PubMed 8464434
Nicholl DDM, Ahmed SB, Loewen AHS, Hemmelgarn BR, Sola DY, Beecroft JM, Turin TC, Hanly PJ. Declining kidney function increases the prevalence of sleep apnea and nocturnal hypoxia. Chest. 2012 Jun;141(6):1422-1430. doi: 10.1378/chest.11-1809. Epub 2012 Jan 5.
PubMed 22222188
Perl J, Unruh ML, Chan CT. Sleep disorders in end-stage renal disease: 'Markers of inadequate dialysis'? Kidney Int. 2006 Nov;70(10):1687-93. doi: 10.1038/sj.ki.5001791. Epub 2006 Sep 13.
PubMed 16969388
Hanly PJ, Ahmed SB. Sleep apnea and the kidney: is sleep apnea a risk factor for chronic kidney disease? Chest. 2014 Oct;146(4):1114-1122. doi: 10.1378/chest.14-0596.
PubMed 25288001
Beecroft J, Duffin J, Pierratos A, Chan CT, McFarlane P, Hanly PJ. Enhanced chemo-responsiveness in patients with sleep apnoea and end-stage renal disease. Eur Respir J. 2006 Jul;28(1):151-8. doi: 10.1183/09031936.06.00075405. Epub 2006 Mar 1.
PubMed 16510459
Faulx MD, Storfer-Isser A, Kirchner HL, Jenny NS, Tracy RP, Redline S. Obstructive sleep apnea is associated with increased urinary albumin excretion. Sleep. 2007 Jul;30(7):923-9. doi: 10.1093/sleep/30.7.923.
PubMed 17682664
Zoccali C, Mallamaci F, Tripepi G. Nocturnal hypoxemia predicts incident cardiovascular complications in dialysis patients. J Am Soc Nephrol. 2002 Mar;13(3):729-733. doi: 10.1681/ASN.V133729.
PubMed 11856778
Nicholl DD, Hanly PJ, Poulin MJ, Handley GB, Hemmelgarn BR, Sola DY, Ahmed SB. Evaluation of continuous positive airway pressure therapy on renin-angiotensin system activity in obstructive sleep apnea. Am J Respir Crit Care Med. 2014 Sep 1;190(5):572-80. doi: 10.1164/rccm.201403-0526OC.
PubMed 25033250
Kuzniar TJ, Klinger M. Sleep apnea, continuous positive airway pressure, and renal health. Am J Respir Crit Care Med. 2014 Sep 1;190(5):486-7. doi: 10.1164/rccm.201407-1359ED. No abstract available.
PubMed 25171309
Ahmed SB, Ronksley PE, Hemmelgarn BR, Tsai WH, Manns BJ, Tonelli M, Klarenbach SW, Chin R, Clement FM, Hanly PJ. Nocturnal hypoxia and loss of kidney function. PLoS One. 2011 Apr 29;6(4):e19029. doi: 10.1371/journal.pone.0019029.
PubMed 21559506
Sakaguchi Y, Hatta T, Hayashi T, Shoji T, Suzuki A, Tomida K, Okada N, Rakugi H, Isaka Y, Tsubakihara Y. Association of nocturnal hypoxemia with progression of CKD. Clin J Am Soc Nephrol. 2013 Sep;8(9):1502-7. doi: 10.2215/CJN.11931112. Epub 2013 Jun 6.
PubMed 23744006

Want to know more?

Jaime Corral, MD

+34-927256204

jcorral@separ.es

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 6 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of CPAP in the Worsening of Renal Function in Early Stages of Chronic Kidney Disease (CKD)
ClinicalTrials.gov ID: NCT03319888
Acronym / sponsor ID: Renas / PI15/00137
Conditions: Chronic Kidney Insufficiency, Sleep Apnea
Keywords: CPAP, Chronic kidney disease, sleep apnea
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 700 participants (estimated)
Lead sponsor: Sociedad Española de Neumología y Cirugía TorácicaUniversity, hospital or other
Study start: 20 Nov 2017 (actual)
Primary completion: 20 Nov 2019 (estimated)
Study completion: 20 May 2020 (estimated)
First posted: 24 Oct 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
cpap group	Experimental	Device: CPAPCPAP treatment plus conservative treatment with lifestyle modifications.
control group	Active comparator	Other: conservative treatmentConservative treatment with lifestyle modifications.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CPAPcontinuous positive pressure in the airway	Device	cpap group
conservative treatmentconservative treatment group with lifestyle modifications	Other	control group

Primary outcome

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

12 secondary outcomes

To estimate the prevalence of OSAS in patients with CKD stages G1-3 KDIGO
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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 wheather CPAP reduces the percentage of patients achieving replacement therapy
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Evaluate wheather treatment with CPAP reduces the incidence of cardiovascular events
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Evaluate wheather treatment with CPAP reduces the mortality
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)
Evaluation of the cost-effectiveness of treatment groups with and without CPAP
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)
Compare the evolution of inflammation-endothelial disfunction markers in NO-OSAS group versus OSAS group
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)
Compare the worsening of the glomerular filtration in NO OSAS group versus OSAS group
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)
Compare the percentage of patients achieving renal replacement therapy in NO OSAS group versus OSAS group
Time frame: after 2 years of followed up (each patient will be followed up for at least 2 years-range from 2 to 3 years)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
Background: PubMed 23727169Jha V, Garcia-Garcia G, Iseki K, Li Z, Naicker S, Plattner B, Saran R, Wang AY, Yang CW. Chronic kidney disease: global dimension and perspectives. Lancet. 2013 Jul 20;382(9888):260-72. doi: 10.1016/S0140-6736(13)60687-X. Epub 2013 May 31.
Background: PubMed 20382326James MT, Hemmelgarn BR, Tonelli M. Early recognition and prevention of chronic kidney disease. Lancet. 2010 Apr 10;375(9722):1296-309. doi: 10.1016/S0140-6736(09)62004-3.
Background: PubMed 20038967Otero A, de Francisco A, Gayoso P, Garcia F; EPIRCE Study Group. Prevalence of chronic renal disease in Spain: results of the EPIRCE study. Nefrologia. 2010;30(1):78-86. doi: 10.3265/Nefrologia.pre2009.Dic.5732. Epub 2009 Dec 14.
Background: PubMed 21398016Lloberes P, Duran-Cantolla J, Martinez-Garcia MA, Marin JM, Ferrer A, Corral J, Masa JF, Parra O, Alonso-Alvarez ML, Teran-Santos J. Diagnosis and treatment of sleep apnea-hypopnea syndrome. Spanish Society of Pulmonology and Thoracic Surgery. Arch Bronconeumol. 2011 Mar;47(3):143-56. doi: 10.1016/j.arbres.2011.01.001. No abstract available. English, Spanish.
Background: PubMed 8464434Young T, Palta M, Dempsey J, Skatrud J, Weber S, Badr S. The occurrence of sleep-disordered breathing among middle-aged adults. N Engl J Med. 1993 Apr 29;328(17):1230-5. doi: 10.1056/NEJM199304293281704.
Background: PubMed 22222188Nicholl DDM, Ahmed SB, Loewen AHS, Hemmelgarn BR, Sola DY, Beecroft JM, Turin TC, Hanly PJ. Declining kidney function increases the prevalence of sleep apnea and nocturnal hypoxia. Chest. 2012 Jun;141(6):1422-1430. doi: 10.1378/chest.11-1809. Epub 2012 Jan 5.
Background: PubMed 16969388Perl J, Unruh ML, Chan CT. Sleep disorders in end-stage renal disease: 'Markers of inadequate dialysis'? Kidney Int. 2006 Nov;70(10):1687-93. doi: 10.1038/sj.ki.5001791. Epub 2006 Sep 13.
Background: PubMed 25288001Hanly PJ, Ahmed SB. Sleep apnea and the kidney: is sleep apnea a risk factor for chronic kidney disease? Chest. 2014 Oct;146(4):1114-1122. doi: 10.1378/chest.14-0596.
Background: PubMed 16510459Beecroft J, Duffin J, Pierratos A, Chan CT, McFarlane P, Hanly PJ. Enhanced chemo-responsiveness in patients with sleep apnoea and end-stage renal disease. Eur Respir J. 2006 Jul;28(1):151-8. doi: 10.1183/09031936.06.00075405. Epub 2006 Mar 1.
Background: PubMed 17682664Faulx MD, Storfer-Isser A, Kirchner HL, Jenny NS, Tracy RP, Redline S. Obstructive sleep apnea is associated with increased urinary albumin excretion. Sleep. 2007 Jul;30(7):923-9. doi: 10.1093/sleep/30.7.923.
Background: PubMed 11856778Zoccali C, Mallamaci F, Tripepi G. Nocturnal hypoxemia predicts incident cardiovascular complications in dialysis patients. J Am Soc Nephrol. 2002 Mar;13(3):729-733. doi: 10.1681/ASN.V133729.
Background: PubMed 25033250Nicholl DD, Hanly PJ, Poulin MJ, Handley GB, Hemmelgarn BR, Sola DY, Ahmed SB. Evaluation of continuous positive airway pressure therapy on renin-angiotensin system activity in obstructive sleep apnea. Am J Respir Crit Care Med. 2014 Sep 1;190(5):572-80. doi: 10.1164/rccm.201403-0526OC.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jaime Corral, MD contact

+34-927256204

jcorral@separ.es

Juan F Masa, PHD contact

+34-927256204

fmasa@separ.es

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CPAP and conservative treatment in people with Chronic Kidney Insufficiency and Sleep Apnea, run by Sociedad Española de Neumología y Cirugía Torácica at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jaime Corral, MD (+34-927256204, jcorral@separ.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: after 2 years of followed up (each patient will be followed up for at least 2 years - range from 2 to 3 years)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03319888, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2018.