An interventional study of CPAP and conservative treatment in Chronic Kidney Insufficiency and Sleep Apnea, sponsored by Sociedad Española de Neumología y Cirugía Torácica. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-06.
Sponsored by Sociedad Española de Neumología y Cirugía Torácica · Not applicable, Interventional, and Treatment
Among 187 studies in Renal Insufficiency, Chronic with a site in Spain — 37 open to participants now, 54 under way, 23 of them phase 3. Renal Insufficiency, Chronic · Spain.
Among the 187 studies in Renal Insufficiency, Chronic with a site in Spain, this one is the 41st largest by planned enrollment of the 153 interventional ones that give a count, is one of 8 that started in 2017, is one of 27 with no phase, and was the 66th registered.
3,094 studies on the registry are indexed under Renal Insufficiency, Chronic; 701 are open to participants now.
Browse Renal Insufficiency, Chronic studies →37 of the 187 studies in Renal Insufficiency, Chronic with a site in Spain are open now. Recruiting first, the newest first:
Cardenal Herrera University · Sites in Spain
Ages 18–85
AstraZeneca · Sites in Spain, United States, Argentina and 24 more countries
Ages 18–99
AstraZeneca · Sites in Spain, United States, Argentina and 34 more countries
Ages 18+
Novartis Pharmaceuticals · Sites in Spain, United States, China and 5 more countries
Ages 2–18
Vifor Fresenius Medical Care Renal Pharma · Sites in Spain, China, Greece and 4 more countries
Ages 12–18
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 434 Renal Insufficiency, Chronic studies recruiting now, 244 (56%) set no upper age limit and 111 (26%) stop at 75 or younger; 45 take children under 18; 80 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
187 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 34 · Phase 3 80 · Phase 4 14
First in 1998; this study’s year is marked. 8 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 700 is above the median of 73 across 2,161 interventional studies indexed under Renal Insufficiency, Chronic.
Median enrollment 252 across the 153 interventional studies, 397 across the 34 observational. Of the 122 that completed or were terminated, 68 (56%) have results posted.
This tab as a report to print or save as PDF → With an account.
124 of 187 have an industry lead sponsor. The 10 most frequent:
Sociedad Española de Neumología y Cirugía Torácica is the lead sponsor of 44 studies on the registry; 3 are open to participants now.
Sociedad Española de Neumología y Cirugía Torácica has 1 study filed under Renal Insufficiency, Chronic — fewer than ten, so there is no comparison to draw.
13 of the studies in Renal Insufficiency, Chronic with a site in Spain that are under way reach primary completion within a year, 8 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06578078Phase 3Fundación para la Investigación del Hospital Clínico de ValenciaA Clinical Trial to Define the Best Strategy for the Management of Heart Failure in Elderly Patients | 2026-12-30 |
| NCT05196035Phase 3BayerA Study to Learn More About How Well the Study Treatment Finerenone Works, How Safe it is, How it Moves Into, Through, and Out of the Body, and the Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker in Children With Chronic Kidney Disease and Proteinuria | 2027-04-10 |
| NCT07107945Phase 3Boehringer IngelheimA Study to Find Out How EMPAgliflozin is Tolerated and if it Helps Children and Adolescents With Chronic KIDNEY Disease (EMPA-KIDNEY® Kids) | 2027-04-16 |
| NCT03969329Phase 3AmgenA Phase 3 Study of Etelcalcetide in Children With Secondary Hyperparathyroidism Receiving Hemodialysis | 2027-06-30 |
| NCT05374291Phase 3University Medical Center GroningenThe RENAL LIFECYCLE Trial: A RCT to Assess the Effect of Dapagliflozin on Renal and Cardiovascular Outcomes in Patients With Severe CKD | 2027-07 |
Add all 13 to your calendar (.ics) → With an account.
Among the 187 studies in Renal Insufficiency, Chronic with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CPAP treatment plus conservative treatment with lifestyle modifications.
Device: CPAP
Conservative treatment with lifestyle modifications.
Other: conservative treatment
continuous positive pressure in the airway
conservative treatment group with lifestyle modifications
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)
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 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.
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.
Number of participants with CKD and OSAS with a decline in urine albumin to creatinine ratio.
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
Number of participants with CKD and OSAS with a decline in serum cystatin C levels
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
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)
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
number of participants with CKD and OSAS with a change to a higher CKD stage according to eGFR.
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
number of participants with CKD and OSAS who need renal replacement therapy (haemodialysis, peritoneal dialysis or renal transplantation)
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
number of participants with CKD and OSAS who suffered a cardiovascular event (myocardial infarction, stroke, hospitalization for heart failure, atrial fibrillation)
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
number of participants with CKD and OSAS with CPAP treatment who died (all-cause 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
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
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
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)
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
number of participants with NO OSAS versus OSAS who have a worsening of the glomerular filtration.
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
number of participants who need 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)
Plan to share: No
Started Nov 2017 (actual). Primary completion is estimated for Nov 2019, 24 months after the start.
Of 576 non-industry interventional studies with no phase under Renal Insufficiency, Chronic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 45. This study's planned 24 months is close to that.
Counting every sponsor, half of 616 studies reached it within 23 months; a quarter within 10 and three quarters within 45.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.
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Renal Insufficiency, Chronic →
Sociedad Española de Neumología y Cirugía Torácica