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Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)

Primary Purpose

CKD

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Fecal Microbiota Transplantation

Standard of Care for Chronic Kidney Disease

About this trial

This is an interventional treatment trial for CKD focused on measuring Fecal Microbiota Transplantation (FMT), Chronic Kidney Disease (CKD)

Eligibility Criteria

16 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Being diagnosed with chronic kidney disease without WMT in the past three months Able to tolerate colonoscopy Receiving rescue FMT from the China Microbiota Transplantation System Suitable and compatible with WMT treatment Patients who can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form Able to receive follow-up examinations, follow-up examinations and retain specimens on time Exclusion Criteria: Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT Antibiotics or probiotics within 4 weeks prior to enrollment Patients with anxiety, depression, mental or legal disabilities Patients with fulminant type, massive bloody stools, and severe illness unable to tolerate colonoscopy Other patients deemed unsuitable for enrollment by the investigator

Sites / Locations

the Second Affiliated of Nanjing Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

Washed Microbiota Transplantation to treat Chronic Kidney Disease

Standard of Care for Chronic Kidney Disease

Arm Description

Outcomes

Primary Outcome Measures

Changes in Blood Creatinine

Patients' Laboratory Change from Baseline Blood Creatinine

Changes in 24-hour Urine Protein

Patients' Laboratory Change from Changes in 24-hour urine protein

Secondary Outcome Measures

Full Information

NCT ID

NCT05838118

First Posted

April 8, 2023

Last Updated

April 20, 2023

Sponsor

The Second Hospital of Nanjing Medical University

1. Study Identification

Unique Protocol Identification Number

NCT05838118

Brief Title

Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)

Official Title

Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2023 (Anticipated)

Primary Completion Date

December 31, 2024 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Second Hospital of Nanjing Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

Wahsed microbiota transplantation (WMT) is a novel and promising therapeutic method for Chronic Kidney Disease (CKD). This clinical trail aims to evaluate the efficacy and safety of WMT in the treatment of CKD.

Detailed Description

Although the therapeutic methods progress, numerous patients with Chronic Kidney Disease (CKD) can not avoid the clinical outcome of end-stage renal disease. CKD still needs novel treatment to significantly improve the survival quality of the patients. Gut microbiota has been verified to have relation with immunity. Immunity plays a role in many chronic kidney disease, such as IgA nephropathy, membranous nephropathy and so on. Fecal microbiota transplantation (FMT) is a novel, safe, convenient therapeutic treatment which transplant gut microbiota from donor to patient to rebuild a gut microecology. This study aims to evaluate the efficacy and safety of FMT in CKD patients. Patients in this study will undergo three times WMT. The primary outcome measure was the clinical remission efficacy rate in the CKD patients. The secondary outcome measure was the safety of WMT in CKD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

CKD

Keywords

Fecal Microbiota Transplantation (FMT), Chronic Kidney Disease (CKD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Washed Microbiota Transplantation to treat Chronic Kidney Disease

Arm Type

Other

Arm Title

Standard of Care for Chronic Kidney Disease

Arm Type

Other

Intervention Type

Drug

Intervention Name(s)

Fecal Microbiota Transplantation

Intervention Description

Biologically active human fecal fluid (donor stool) is provided in fluid form.

Intervention Type

Other

Intervention Name(s)

Standard of Care for Chronic Kidney Disease

Intervention Description

Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.

Primary Outcome Measure Information:

Title

Changes in Blood Creatinine

Description

Patients' Laboratory Change from Baseline Blood Creatinine

Time Frame

1 week, 4 week, 12 week

Title

Changes in 24-hour Urine Protein

Description

Patients' Laboratory Change from Changes in 24-hour urine protein

Time Frame

1 week, 4 week, 12 week

Other Pre-specified Outcome Measures:

Title

Rate of Adverse Events

Description

The rate of adverse events after Washed microbiota transplantation

Time Frame

4 week, 12 week following WMT

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Faming Zhang

Phone

02556662092

fzhang@njmu.edu.cn

Facility Information:

Facility Name

the Second Affiliated of Nanjing Medical University

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210011

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Faming Zhang

Phone

02556662092

fzhang@njmu.edu.cn

12. IPD Sharing Statement

Citations:

PubMed Identifier

34614411

Citation

Zhu H, Cao C, Wu Z, Zhang H, Sun Z, Wang M, Xu H, Zhao Z, Wang Y, Pei G, Yang Q, Zhu F, Yang J, Deng X, Hong Y, Li Y, Sun J, Zhu F, Shi M, Qian K, Ye T, Zuo X, Zhao F, Guo J, Xu G, Yao Y, Zeng R. The probiotic L. casei Zhang slows the progression of acute and chronic kidney disease. Cell Metab. 2021 Oct 5;33(10):2091-2093. doi: 10.1016/j.cmet.2021.08.015. No abstract available.

Results Reference

result

PubMed Identifier

28469156

Citation

Xu KY, Xia GH, Lu JQ, Chen MX, Zhen X, Wang S, You C, Nie J, Zhou HW, Yin J. Impaired renal function and dysbiosis of gut microbiota contribute to increased trimethylamine-N-oxide in chronic kidney disease patients. Sci Rep. 2017 May 3;7(1):1445. doi: 10.1038/s41598-017-01387-y.

Results Reference

result

PubMed Identifier

35986026

Citation

Xu L, Guo J, Moledina DG, Cantley LG. Immune-mediated tubule atrophy promotes acute kidney injury to chronic kidney disease transition. Nat Commun. 2022 Aug 19;13(1):4892. doi: 10.1038/s41467-022-32634-0.

Results Reference

result

PubMed Identifier

33754024

Citation

Lu J, Chen PP, Zhang JX, Li XQ, Wang GH, Yuan BY, Huang SJ, Liu XQ, Jiang TT, Wang MY, Liu WT, Ruan XZ, Liu BC, Ma KL. GPR43 deficiency protects against podocyte insulin resistance in diabetic nephropathy through the restoration of AMPKalpha activity. Theranostics. 2021 Mar 4;11(10):4728-4742. doi: 10.7150/thno.56598. eCollection 2021.

Results Reference

result

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Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)

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