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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Fecal microbiome taxonomy (Shannon-Index) | Measured by 16S amplicon sequencing | Change from Baseline at 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Functional capacity of gut microbiota | Measured by metagenome sequencing | Change from Baseline at 24 weeks |
| Frequency of circulating T-cell subtypes | Measured by flow cytometry (%) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hendrik Bartolomaeus, MD | Contact | +49 30 450 540 464 | hendrik.bartolomaeus@charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Nicola Wilck, MD | Charite University, Berlin, Germany | Principal Investigator |
| Hendrik Bartolomaeus, MD | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Experimental and Clinical Research Center | Recruiting | Berlin | 13125 | Germany |
Individual participant data that underlie the results of reported articles (text, tables, figures, supplemental data) will be shared after deidentification.
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Beginning in 2 months and ending 36 months following article publication.
Researchers who provide a methodologically sound proposal.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Plasma, serum, urine, stool, and peripheral blood mononuclear cells will be collected.
| Change from Baseline at 24 weeks |
| Serum tryptophan metabolites concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks |
| Serum short-chain fatty acid concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks |
| Fecal tryptophan metabolites concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks |
| Fecal short-chain fatty acid concentration | Measured by mass spectrometry | Change from Baseline at 24 weeks |
| Office systolic blood pressure | Mean of five consecutive blood pressure measurements (mmHg) | Change from Baseline at 24 weeks |
| Office diastolic blood pressure | Mean of five consecutive blood pressure measurements (mmHg) | Change from Baseline at 24 weeks |
| Body fat content | Measured by bioelectrical impedance analysis (%) | Change from Baseline at 24 weeks |
| Fat free mass | Measured by bioelectrical impedance analysis (%) | Change from Baseline at 24 weeks |
| Anja Mähler, PhD |
| Charite University, Berlin, Germany |
| Principal Investigator |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |