Antibody-mediated RejectionNCT02533596
Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
An observational study of Antibody-mediated Rejection and Autoimmune Reaction Mediated by Immune Complex, run by Hannover Medical School at 1 site in Germany.
Trial summary
Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Antibody-mediated Rejection, Autoimmune Reaction Mediated by Immune Complex
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2010to Mar 2011
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Tertiary hospital patients after kidney transplantation with humoral rejection and patients with other antibody mediated diseases.
Who may be able to join
- indication for TPE
- age between 18 and 80 years
- written informed consent
Who cannot join
- need for fresh-frozen plasma as replacement fluid
- participation in another study
Trial locations and contacts
1 site in 1 country.
About this study
Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. However, in many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. The aim of this study is to determine adipokine and cardiac biomarker removal during TPE therapy.
Read the detailed description
We performed a observational prospective single-centered study. Every patient received two consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system. Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange volume of every TPE treatment was 1.1-times the individual calculated total plasma volume, using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in every treatment. Blood samples for measurement of different adipokines (resistin, leptin, soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and second TPE session.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage decrease in serum levels of C-reactive protein by TPE
Elimination of C-reactive protein by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Measured: Up to five days after enrollment
Percentage decrease in serum levels of Troponin T by TPE
Elimination of cardiac biomarkers Troponin T by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Measured: Up to five days after enrollment
Percentage decrease in serum levels of procalcitonin by TPE
Elimination of procalcitonin by TPE measured by the decrease in serum
Measured: Up to five days after enrollment
Percentage decrease in serum levels of NT-proBNP by TPE
Elimination of NT-proBNP by TPE measured
Measured: Up to five days after enrollment
Secondary outcomes (6)
Percentage decrease in serum levels of adipokines by TPE
Elimination of adipokines by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Measured: Up to five days after enrollment
Total eliminated amount of Troponin T by TPE
Elimination of Troponin T by TPE measured by the total eliminated amount in the exchanged plasma.
Measured: Up to five days after enrollment
Total eliminated amount of NT-proBNP by TPE
Elimination of NT-proBNP by TPE measured by the total eliminated amount in the exchanged plasma.
Measured: Up to five days after enrollment
Total eliminated amount of procalcitonin by TPE
Elimination of procalcitonin by TPE measured by the total eliminated amount in the exchanged plasma.
Measured: Up to five days after enrollment
Total eliminated amount of C-reactive protein by TPE
Elimination of C-reactive protein by TPE measured by the total eliminated amount in the exchanged plasma.
Measured: Up to five days after enrollment
Total eliminated amount of adipokines by TPE
Elimination of adipokines by TPE measured by the total eliminated amount in the exchanged plasma.
Measured: Up to five days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2015 (estimated)
- Study startSep 2010
- Primary completionDec 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibody-mediated RejectionStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan T Kielstein, Prof., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02533596
- Sponsor's protocol ID
- TPE-5343-2010
- Status last verified
- Feb 2015
- First submitted
- 27 Feb 2015
- Last updated
- 27 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elimination of Cardiac and Inflammatory Biomarkers and Adipokines by Therapeutic Plasma Exchange
- ClinicalTrials.gov ID
- NCT02533596
- Acronym / sponsor ID
- TPE-5343-2010
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 27 Aug 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.
Therapeutic plasma exchange (TPE) is an established treatment modality for the acute removal of pathophysiological relevant mediators in various diseases. Adipokines have recently been found to play an important role in a variety of immunologic diseases. However, in many of these disease states cardiac and inflammatory involvement is common and biomarkers are routinely used for diagnosis or assessment of therapeutic success. The effect of TPE on biomarkers used in the clinical routine has not been investigated. The aim of this study is to determine adipokine and cardiac biomarker removal during TPE therapy.
Detailed description
We performed a observational prospective single-centered study. Every patient received two consecutive therapeutic plasma exchange (TPE) sessions during the study. Plasma exchange therapy was performed using either the Spectra Optia® or the Octo Nova® apheresis system. Anticoagulation was applied either by heparin or citrate. The prescribed dose of exchange volume of every TPE treatment was 1.1-times the individual calculated total plasma volume, using the Nadler-Allen equation. A substitute fluid with 5% albumin concentration was used in every treatment. Blood samples for measurement of different adipokines (resistin, leptin, soluble ICAM-1, soluble CD40 ligand, monocyte chemoattractant protein-1 (MCP-1), soluble tumor necrosis factor receptor (sTNF-R) as well as cardiac and inflammatory biomarkers and routine chemistry were drawn before (pre-TPE) and at the end (post-TPE) of the first and second TPE session.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Tertiary hospital patients after kidney transplantation with humoral rejection and patients with other antibody mediated diseases.
Key inclusion criteria (3 listed)
- indication for TPE
- age between 18 and 80 years
- written informed consent
Key exclusion criteria (2 listed)
- need for fresh-frozen plasma as replacement fluid
- participation in another study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage decrease in serum levels of C-reactive protein by TPE
Time frame: Up to five days after enrollment
Elimination of C-reactive protein by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Percentage decrease in serum levels of Troponin T by TPE
Time frame: Up to five days after enrollment
Elimination of cardiac biomarkers Troponin T by TPE measured by the decrease in serum levels after two consecutive TPE sessions.
Percentage decrease in serum levels of procalcitonin by TPE
Time frame: Up to five days after enrollment
Elimination of procalcitonin by TPE measured by the decrease in serum
Percentage decrease in serum levels of NT-proBNP by TPE
Time frame: Up to five days after enrollment
Elimination of NT-proBNP by TPE measured
6 secondary outcomes
Percentage decrease in serum levels of adipokines by TPE
Time frame: Up to five days after enrollment
Total eliminated amount of Troponin T by TPE
Time frame: Up to five days after enrollment
Total eliminated amount of NT-proBNP by TPE
Time frame: Up to five days after enrollment
Total eliminated amount of procalcitonin by TPE
Time frame: Up to five days after enrollment
Total eliminated amount of C-reactive protein by TPE
Time frame: Up to five days after enrollment
Total eliminated amount of adipokines by TPE
Time frame: Up to five days after enrollment
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 27 Aug 2015.
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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.
Jan T Kielstein, Prof. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibody-mediated Rejection and Autoimmune Reaction Mediated by Immune Complex, run by Hannover Medical School at 1 site 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 3 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 27 Aug 2015. 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 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?
Percentage decrease in serum levels of C-reactive protein by TPE (time frame: Up to five days after enrollment). The study lists 4 primary outcomes in all. 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 27 Aug 2015; AzTrials last refreshed its copy on 8 Nov 2026.