An interventional study of HD, Magnetic Resonance Imaging (MRI) scans in Renal Failure, Cardiovascular Diseases and Congenital Disorders, sponsored by Fresenius Medical Care Deutschland GmbH. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-01-15.
Sponsored by Fresenius Medical Care Deutschland GmbH (part of Fresenius Medical Care) · Not applicable, Interventional, and Treatment
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Among 16 studies in Renal Insufficiency by Fresenius Medical Care — 4 open to participants now, 4 under way, none of them phase 3. Renal Insufficiency · Fresenius Medical Care.
Among the 16 studies in Renal Insufficiency by Fresenius Medical Care, this one is the 9th largest by enrollment of the 11 interventional ones that give a count, is one of 2 that started in 2018, is one of 10 with no phase, and was the 2nd registered.
1,412 studies on the registry are indexed under Renal Insufficiency; 145 are open to participants now.
Browse Renal Insufficiency studies →4 of the 16 studies in Renal Insufficiency by Fresenius Medical Care are open now, in 2 countries. Recruiting first, the newest first:
Fresenius Medical Care Deutschland GmbH · Sites in Germany
Fresenius Medical Care Deutschland GmbH · Sites in Czechia, Germany
Ages up to 18
Fresenius Medical Care Deutschland GmbH
Ages 18+
Fresenius Medical Care Deutschland GmbH · Sites in Germany
Ages 1+
By country, each count listing its studies:
Of the 91 Renal Insufficiency studies recruiting now, 48 (53%) set no upper age limit and 18 (20%) stop at 75 or younger; 8 take children under 18; 15 take healthy volunteers.
This study: 18 Years to 80 Years · 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.
16 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2018.
This study's enrollment of 17 is below the median of 40 across 1,060 interventional studies indexed under Renal Insufficiency.
Median enrollment 49 across the 11 interventional studies, 119 across the 5 observational. Of the 11 that completed or were terminated, 0 (0%) have results posted.
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This study is registered under Fresenius Medical Care Deutschland GmbH, one of the names counted as Fresenius Medical Care. Under that name alone:
Fresenius Medical Care Deutschland GmbH is the lead sponsor of 36 studies on the registry; 7 are open to participants now.
2 of the studies in Renal Insufficiency by Fresenius Medical Care that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06390592Fresenius Medical Care Deutschland GmbHClinical Performance of the Therapy Option FlexPoint of the PD Cycler Sleep•Safe Harmony | 2027-08 |
| NCT07679568Fresenius Medical Care Deutschland GmbHAnalysis of Continuous Kidney Replacement Therapy (CKRT) Treatments With multiFlux Hemofilters Using Regional Citrate Anticoagulation (RCA) or Systemic Heparin Anticoagulation | 2027-10 |
Add all 2 to your calendar (.ics) → With an account.
Among the 16 studies in Renal Insufficiency by Fresenius Medical Care, from their registry updates:
Nothing recorded among them since 2026-09-25.
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The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The effects of a standard prescription haemodialysis (dialysate temperature 37 C) will be compared to a thermocontrolled (or isothermic) haemodialysis prescription to ascertain if thermocontrolled HD provides a protective effect on organ perfusion and circulatory stress when compared to conventional haemodialysis. The BTM (blood temperature monitor, Fresenius) offers a way to overcome this to regulate thermal balance during dialysis and achieve a neutral thermal balance (isothermic) over the dialysis session. Other dialysis parameters will be standardised between treatment arms using blood volume monitoring (BVM) and clinical assessments.
The purpose of this study is to characterise in detail cardiac, cerebral and renal structure, function and perfusion in patients on haemodialysis (HD) using magnetic imaging techniques. The Primary objectives are to investigate the difference in cardiac perfusion, structure and function between standard HD and thermocontrolled HD using magnetic imaging techniques, to observe the the changes in renal perfusion and oxygenation within one dialysis session and the changes to cerebral perfusion within one dialysis session.
The secondary objectives are to investigate the difference in cerebral perfusion, structure, oedema and function between standard HD and thermocontrolled HD, the difference in renal perfusion and oxygenation between standard HD and thermocontrolled HD and the differences in visual acuity and cognitive assessment across a dialysis session and over a dialysis treatment course.
Exclusion Criteria:
Instability on dialysis in 4 weeks prior to recruitment leading to either:
Inclusion 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.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
HD with constant temperature of 37°C, MRI scans of the heart, kidneys and brain during HD sessions
Other: HD, Magnetic Resonance Imaging (MRI) scans
HD applying the Blood Temperature Monitor (BTM), MRI scans of the heart, kidneys and brain during HD sessions
Other: HD, Magnetic Resonance Imaging (MRI) scans
HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
Change in cardiac output during standard HD and thermocontrolled HD
Change in cardiac output during standard HD and thermocontrolled HD using Phase Contrast Magnetic Resonance Imaging (PC-MRI)
Time frame: after 2 and 4 weeks after randomisation
Change in renal perfusion during standard HD and thermocontrolled HD
Change in renal perfusion using Arterial Spin Labelling (ASL) and renal artery flow using PC-MRI
Time frame: after 2 and 4 weeks after randomisation
Change in cerebral perfusion during standard HD and thermocontrolled HD
Change in cerebral perfusion during standard HD and thermocontrolled HD using ASL
Time frame: after 2 and 4 weeks after randomisation
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in May 2019, 16 months.
Of 31 industry-sponsored interventional studies with no phase under Renal Insufficiency, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 27. This study's 16 months is close to that.
Counting every sponsor, half of 149 studies reached it within 22 months; a quarter within 8 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Fresenius Medical Care Deutschland GmbH →