LONGitudinal Multi-omics Phenotyping of KIDney Function Alteration

NCT ID: NCT05570929

Last Updated: 2024-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-07

Study Completion Date

2026-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Kidney Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kidney Donor

Defined as a human individual donating a kidney

No interventions assigned to this group

Kidney Recipient

Defined as a patient suffering from chronic kidney disease being the recipient of a kidney transplant

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Body-Mass-Index 18,5 - 34,9 kg/m2
* Planned living kidney donation / transplantation

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Till Schütte

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nicola Wilck, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Hendrik Bartolomaeus, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Anja Mähler, PhD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

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Experimental and Clinical Research Center

Berlin, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Hendrik Bartolomaeus, MD

Role: CONTACT

+49 30 450 540 464

Facility Contacts

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Hendrik Bartolomaeus, MD

Role: primary

+49 30 450 540 464

Other Identifiers

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LONGKID

Identifier Type: -

Identifier Source: org_study_id

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