End Stage Renal Failure on DialysisBicMagNCT02621762
Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
A study testing Magnesium and Bicarbonate in people with End Stage Renal Failure on Dialysis and Vascular Calcification, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 111 years
- Conditions the study is for
- End Stage Renal Failure on Dialysis, Vascular Calcification
- What is being tested?
- Magnesium and Bicarbonate
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2015to May 2016
- 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 to 111 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female hemodialysis patients ≥ 18 years of age
- Negative pregnancy test of female patients in child-bearing age
- The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
- Start of chronic hemodialysis treatment ≥ 3 months ago
- HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
- Magnesium in venous plasma ≤ 1.45 mmol/L before the start of the first dialysis of the week
- T50 ≥ 200 minutes.
Who cannot join
- Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
- History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Bern Inselspital
Bern, Canton of Bern, 3008
About this study
The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.
- Being tested
- Magnesium, Bicarbonate
- Medical subject headings
- Vascular Calcification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MagnesiumDevice
Magnesium in dialysate increased
BicarbonateDevice
Bicarbonate in dialysate increased
| Study group | Role | What they receive |
|---|---|---|
| Mg first | Experimental | Receives MgCl2 first, MgCl2 and Bicarbonate in second phase Receives: Device: Magnesium; Device: Bicarbonate |
| Bicarbonate first | Experimental | Receives Bicarbonate first, MgCl2 and Bicarbonate in second phase Receives: Device: Magnesium; Device: Bicarbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of treatment on serum calcification propensity, measured by T50
T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)
Measured: 7 weeks
Secondary outcomes (1)
Number of participants with treatment-related adverse events
Measured: 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal Failure on DialysisStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dominik Uehlinger, Prof Dr.med., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02621762
- Sponsor's protocol ID
- 293_15
- Acronym
- BicMag
- Status last verified
- Sep 2017
- First submitted
- 26 Nov 2015
- Last updated
- 26 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.
PubMed 22956818
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study to Investigate the Effects of Increased Dialysate Magnesium and Dialysate Bicarbonate on the Calcification Propensity of Serum
- ClinicalTrials.gov ID
- NCT02621762
- Acronym / sponsor ID
- BicMag / 293_15
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 3 Dec 2015 (estimated)
- 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.
The study aims to determine the effect size of magnesium and bicarbonate supplementation as a basis for future randomized controlled trials aiming at the T50-guided improvement of hard clinical endpoints in dialysis patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mg first | Experimental | Device: Magnesium, Device: BicarbonateReceives MgCl2 first, MgCl2 and Bicarbonate in second phase |
| Bicarbonate first | Experimental | Device: Magnesium, Device: BicarbonateReceives Bicarbonate first, MgCl2 and Bicarbonate in second phase |
Who may qualify
- Ages
- 18 to 111 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female hemodialysis patients ≥ 18 years of age
- Negative pregnancy test of female patients in child-bearing age
- The patients have to be able to understand the character and the individual impact of the clinical study and they have to give written informed consent to participate in the study
- Start of chronic hemodialysis treatment ≥ 3 months ago
- HCO3- in venous plasma ≤23 mmol/L before the start of the last dialysis of the week
Key exclusion criteria (2 listed)
- Pregnant or lactating subjects. A blood pregnancy test will be performed at the screening visit in female patients of childbearing age.
- History of alcohol abuse, illicit drug use, significant mental illness, physical dependence to any opioid, or any history of drug abuse or addiction within 12 months of study enrolment
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 |
|---|---|---|
| MagnesiumMagnesium in dialysate increased | Device | Bicarbonate first, Mg first |
| BicarbonateBicarbonate in dialysate increased | Device | Bicarbonate first, Mg first |
Primary outcome
Effect of treatment on serum calcification propensity, measured by T50
Time frame: 7 weeks
T50: Transformation time of primary calciprotein particles to secondary calciprotein particles (Pasch et al, 2012)
1 secondary outcome
Number of participants with treatment-related adverse events
Time frame: 7 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- Background: PubMed 22956818Pasch A, Farese S, Graber S, Wald J, Richtering W, Floege J, Jahnen-Dechent W. Nanoparticle-based test measures overall propensity for calcification in serum. J Am Soc Nephrol. 2012 Oct;23(10):1744-52. doi: 10.1681/ASN.2012030240. Epub 2012 Sep 6.
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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.
Dominik Uehlinger, Prof Dr.med. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnesium and Bicarbonate in people with End Stage Renal Failure on Dialysis and Vascular Calcification, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 7 inclusion and 2 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: finished, as of the sponsor's last update on 26 Sep 2017. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of treatment on serum calcification propensity, measured by T50 (time frame: 7 weeks). 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 NCT02621762, which also lists 1 linked publication.
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 26 Sep 2017.