Chronic Kidney DiseasesNCT05570929
LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration
An observational study of Chronic Kidney Diseases, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 7 Feb 2023to 1 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with chronic kidney disease
Who may be able to join
- Body-Mass-Index 18,5 - 34,9 kg/m2
- Planned living kidney donation / transplantation
Who cannot join
- Clinically relevant heart, lung, liver, and kidney diseases
- Postoperative phase
- Acute infections
- Vegan diet
- Change of body weight of more than 10% in the month prior to study entry
- Known drug or alcohol abuse
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Experimental and Clinical Research Center
Berlin, 13125
Hendrik Bartolomaeus, MD, +49 30 450 540 464, hendrik.bartolomaeus@charite.de
About this study
Official title: Observation of Alterations in Kidney Function, Immune System and Gut Mircobiota After Living Donor Kidney Transplantation
This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.
- Conditions
- Chronic Kidney Diseases
- Keywords
- Short chain fatty acids, Shannon-Index, Microbial diversity, Home sampling, Kidney transplant
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Kidney Donor | Defined as a human individual donating a kidney | |
| Kidney Recipient | Defined as a patient suffering from chronic kidney disease being the recipient of a kidney transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal microbiome taxonomy (Shannon-Index)
Measured by 16S amplicon sequencing
Measured: Change from Baseline at 24 weeks
Secondary outcomes (10)
Functional capacity of gut microbiota
Measured by metagenome sequencing
Measured: Change from Baseline at 24 weeks
Frequency of circulating T-cell subtypes
Measured by flow cytometry (%)
Measured: Change from Baseline at 24 weeks
Serum tryptophan metabolites concentration
Measured by mass spectrometry
Measured: Change from Baseline at 24 weeks
Serum short-chain fatty acid concentration
Measured by mass spectrometry
Measured: Change from Baseline at 24 weeks
Fecal tryptophan metabolites concentration
Measured by mass spectrometry
Measured: Change from Baseline at 24 weeks
Fecal short-chain fatty acid concentration
Measured by mass spectrometry
Measured: Change from Baseline at 24 weeks
Office systolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Measured: Change from Baseline at 24 weeks
Office diastolic blood pressure
Mean of five consecutive blood pressure measurements (mmHg)
Measured: Change from Baseline at 24 weeks
Body fat content
Measured by bioelectrical impedance analysis (%)
Measured: Change from Baseline at 24 weeks
Fat free mass
Measured by bioelectrical impedance analysis (%)
Measured: Change from Baseline at 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2022
- Study start7 Feb 2023
- Primary completion1 Nov 2025 (estimated)
- Study completion1 Nov 2026 (estimated)
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.
- More trials run by Charite University, Berlin, GermanyThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Till Schütte, Charite University, Berlin, Germany
- Investigators
- Nicola Wilck, MD, Principal investigator, Charite University, Berlin, GermanyHendrik Bartolomaeus, MD, Principal investigator, Charite University, Berlin, GermanyAnja Mähler, PhD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570929
- Sponsor's protocol ID
- LONGKID
- Status last verified
- Jun 2024
- First submitted
- 28 Sep 2022
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation of Alterations in Kidney Function, Immune System and Gut Mircobiota After Living Donor Kidney Transplantation
- ClinicalTrials.gov ID
- NCT05570929
- Acronym / sponsor ID
- LONGKID
- Conditions
- Chronic Kidney Diseases
- Keywords
- Short chain fatty acids, Shannon-Index, Microbial diversity, Home sampling, Kidney transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- 7 Feb 2023 (actual)
- Primary completion
- 1 Nov 2025 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Oct 2022 (actual)
- 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.
This is a longitudinal observation of kidney function, immune system and gut microbiota before and 24 weeks after a live kidney transplantation conducted in donor and recipient pairs living in the same household. Outcome measures include kidney function, body composition, blood pressure, gut microbiome composition, metabolomics and immune cell states.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney Donor | – | –Defined as a human individual donating a kidney |
| Kidney Recipient | – | –Defined as a patient suffering from chronic kidney disease being the recipient of a kidney transplant |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic kidney disease
Key inclusion criteria (2 listed)
- Body-Mass-Index 18,5 - 34,9 kg/m2
- Planned living kidney donation / transplantation
Key exclusion criteria (6 listed)
- Clinically relevant heart, lung, liver, and kidney diseases
- Postoperative phase
- Acute infections
- Vegan diet
- Change of body weight of more than 10% in the month prior to study entry
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
Fecal microbiome taxonomy (Shannon-Index)
Time frame: Change from Baseline at 24 weeks
Measured by 16S amplicon sequencing
10 secondary outcomes
Functional capacity of gut microbiota
Time frame: Change from Baseline at 24 weeks
Frequency of circulating T-cell subtypes
Time frame: Change from Baseline at 24 weeks
Serum tryptophan metabolites concentration
Time frame: Change from Baseline at 24 weeks
Serum short-chain fatty acid concentration
Time frame: Change from Baseline at 24 weeks
Fecal tryptophan metabolites concentration
Time frame: Change from Baseline at 24 weeks
Fecal short-chain fatty acid concentration
Time frame: Change from Baseline at 24 weeks
Office systolic blood pressure
Time frame: Change from Baseline at 24 weeks
Office diastolic blood pressure
Time frame: Change from Baseline at 24 weeks
Body fat content
Time frame: Change from Baseline at 24 weeks
Fat free mass
Time frame: Change from Baseline at 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
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Effects of Horticultural Therapy on Acute Stress and Salivary Cortisol Levels in Hemodialysis Patients
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Enrolling by invitationObservational study
Assessment of Worldwide Acute Kidney Injury Epidemiology in Neonates 2.0
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RecruitingPhase 4
Effect of Low Protein Diet on Top of Dapagliflozin on Chronic Kidney Disease in Patients With Type 2 Diabetes Mellitus
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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.
Nicola Wilck, MD principal investigator
Charite University, Berlin, Germany
Hendrik Bartolomaeus, MD principal investigator
Charite University, Berlin, Germany
Anja Mähler, PhD principal investigator
Charite University, Berlin, Germany
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 Chronic Kidney Diseases, run by Charite University, Berlin, Germany 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 2 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 1 Jul 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hendrik Bartolomaeus, MD (+49 30 450 540 464, hendrik.bartolomaeus@charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal microbiome taxonomy (Shannon-Index) (time frame: Change from Baseline at 24 weeks). 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 1 Jul 2024.