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

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

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.

Study Overview

• Status: Recruiting
• Conditions: CKD
• Intervention / Treatment: Drug: Fecal Microbiota Transplantation; Other: Standard of Care for Chronic Kidney Disease

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faming Zhang; Phone Number: 02556662092; Email: fzhang@njmu.edu.cn

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210011
      • Recruiting
      • the Second Affiliated of Nanjing Medical University
      • Contact: Faming Zhang; Phone Number: 02556662092; Email: fzhang@njmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Washed Microbiota Transplantation to treat Chronic Kidney Disease	Drug: Fecal Microbiota Transplantation; Biologically active human fecal fluid (donor stool) is provided in fluid form.
Other: Standard of Care for Chronic Kidney Disease	Other: Standard of Care for Chronic Kidney Disease; Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Blood Creatinine	Patients' Laboratory Change from Baseline Blood Creatinine	1 week, 4 week, 12 week
Changes in 24-hour Urine Protein	Patients' Laboratory Change from Changes in 24-hour urine protein	1 week, 4 week, 12 week

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Adverse Events	The rate of adverse events after Washed microbiota transplantation	4 week, 12 week following WMT

Collaborators and Investigators

• Sponsor: The Second Hospital of Nanjing Medical University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2023
• Primary Completion (Anticipated): December 31, 2024
• Study Completion (Anticipated): December 31, 2024

Study Registration Dates

• First Submitted: April 8, 2023
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 1, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Chronic Kidney Disease (CKD); Fecal Microbiota Transplantation (FMT)
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic
• Other Study ID Numbers: FamingZhang

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No