Chronic Kidney DiseasesNCT02708368
SOP's for CKD-MBD-Biomarkers
An observational study of Chronic Kidney Diseases, run by RWTH Aachen University at 2 sites in Germany.
Trial summary
CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- blood withdrawal
- How many people
- 32 participants
- Where
- 2 sitesGermany
- Study dates
- 1 Jun 2016to 1 Dec 2017
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients who are regularly on dialysis in the clinics will be selected . Healthy Subjects will be recruited over notices in clinic.
Who may be able to join
- Patients who are regularly (3 times a week) on dialysis in the Maria-Hilf-Clinic or healthy subjects
- Male or Female at the age of at least 18 years
- Patients who will be admitted to the clinics of the University Hospital RWTH Aachen or of the Maria-Hilf-Clinic Mönchengladbach or healthy subjects
- written informed consent form
- Subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel
Who cannot join
- age < 18 years
- subjects who are unwilling or not able to consent
- pregnant or lactating women
- subject has been committed to an institution by legal or regulatory order
- dependency or working relationship with the investigator
- participation in a parallel interventional clinical study
- Hb-value < 10 g/dl
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
Aachen, North Rhine-Westphalia, 52074
Clinic for Nephrology and Diabetology, Hospital St. Franziskus (Maria-Hilf-Clinic)
Mönchengladbach, North Rhine-Westphalia, 41063
About this study
Official title: Investigation to Develop Standard Operating Procedures (SOP) for the Determination of Innovative CKD-MBD(Chronic Kidney Disease - Mineral Bone Disorder)-Serum-(Plasma-)Parameters
CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Clinical pictures of peripheral artery occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. For this reason it makes sense to monitor these patients regularly. For this purpose the determination of different biomarkers would be appropriate for control of the course of disease.
During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP were established as indicators for the disease activity, as diagnostic criteria for the existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death) within the scope of CKD-MBD. For the clinical routine care application of these parameters standard operating procedures (SOP) are missing for the determination method relating to optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.
- Conditions
- Chronic Kidney Diseases
- Being tested
- blood withdrawal
- Keywords
- Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
- Medical subject headings
- Renal Insufficiency, Chronic, Chronic Kidney Disease-Mineral and Bone Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood withdrawalOther
3 times
| Study group | Role | What they receive |
|---|---|---|
| Patients on dialysis | 16 patients on dialysis with a sex ratio 1:1; 8 patients on hemodialysis and 8 patients on hemodiafiltration Receives: Other: blood withdrawal | |
| Healthy Subjects | 16 healthy subjects with a sex ratio 1:1 Receives: Other: blood withdrawal |
What is being measured
The primary outcome is the main question the study is designed to answer.
an optimal analysis of innovative CKD-MBD-Biomarkers
Measured: through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2016 (estimated)
- Study start1 Jun 2016
- Primary completion1 Nov 2016
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02708368
- Sponsor's protocol ID
- 15-109
- Status last verified
- Oct 2022
- First submitted
- 29 Feb 2016
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation to Develop Standard Operating Procedures (SOP) for the Determination of Innovative CKD-MBD(Chronic Kidney Disease - Mineral Bone Disorder)-Serum-(Plasma-)Parameters
- ClinicalTrials.gov ID
- NCT02708368
- Acronym / sponsor ID
- 15-109
- Conditions
- Chronic Kidney Diseases
- Keywords
- Chronic Kidney Disease - Mineral Bone Disorder (CKD-MBD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 1 Nov 2016 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 15 Mar 2016 (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.
CKD-MBD (Chronic Kidney Disease - Mineral and Bone Disorder) is an extensive disease and includes dysfunction of the mineral metabolism, the bone metabolism and cardiovascular diseases in the context of renal insufficiency. Clinical pictures of peripheral artery occlusive disease (PAOD), Coronary artery disease (CAD) and arterial hypertension favours among other main risk factors (smoking, obesity, etc.) additional cardiovascular complications. For this reason it makes sense to monitor these patients regularly. For this purpose the determination of different biomarkers would be appropriate for control of the course of disease.
During various studies the biomarkers FGF23, s-klotho, sclerostin, DKK1, BMP2, YKL-40 und MGP were established as indicators for the disease activity, as diagnostic criteria for the existence of CKD-MBD or as risk markers for the incidence of adverse events (incl. death) within the scope of CKD-MBD. For the clinical routine care application of these parameters standard operating procedures (SOP) are missing for the determination method relating to optimal pre-analytic and analytic procedures. These analyses are necessary to ensure the reproducibility of study results and to transfer these parameters in the clinical daily routine for risk stratification.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients on dialysis | – | Other: blood withdrawal16 patients on dialysis with a sex ratio 1:1; 8 patients on hemodialysis and 8 patients on hemodiafiltration |
| Healthy Subjects | – | Other: blood withdrawal16 healthy subjects with a sex ratio 1:1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are regularly on dialysis in the clinics will be selected . Healthy Subjects will be recruited over notices in clinic.
Key inclusion criteria (5 listed)
- Patients who are regularly (3 times a week) on dialysis in the Maria-Hilf-Clinic or healthy subjects
- Male or Female at the age of at least 18 years
- Patients who will be admitted to the clinics of the University Hospital RWTH Aachen or of the Maria-Hilf-Clinic Mönchengladbach or healthy subjects
- written informed consent form
- Subjects who are contractually capable and mentally able to understand and follow the instructions of the study personnel
Key exclusion criteria (7 listed)
- age < 18 years
- subjects who are unwilling or not able to consent
- pregnant or lactating women
- subject has been committed to an institution by legal or regulatory order
- dependency or working relationship with the investigator
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 |
|---|---|---|
| blood withdrawal3 times | Other | Healthy Subjects, Patients on dialysis |
Primary outcome
an optimal analysis of innovative CKD-MBD-Biomarkers
Time frame: through study completion, an average of 3 months
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 Oct 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by RWTH Aachen University at 2 sites in Germany.
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 5 inclusion and 7 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 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. 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?
an optimal analysis of innovative CKD-MBD-Biomarkers (time frame: through study completion, an average of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2022.