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Antibody

Stem Cell + Kidney Transplant for Renal Disease

Phase 1 & 2

Recruiting

Led By Alice Bertaina, MD

Research Sponsored by Alice Bertaina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Chronic kidney disease (CKD) stage 3 or greater

Anticipated need for kidney transplant due to underlying genetic/immunologic disease such as SIOD, FSGS, Cystinosis, SLE, Membranoproliferative glomerulonephritis, renal vasculitis characterized by positivity of the presence of ANCA, other genetic diseases leading to kidney disease requiring KT, or patients who have rejected a previous KT regardless of the underlying disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up +1 year post-kt

Awards & highlights

Study Summary

This trial is testing a new way to transplant kidneys that doesn't require lifelong immunosuppression.

Who is the study for?

This trial is for patients with certain kidney diseases needing a transplant, who have moderate to severe chronic kidney disease and can consent to the study. They must be able to use birth control if of childbearing potential and match their donor in specific genetic markers. Excluded are those with significant liver dysfunction, uncontrolled medical disorders, active infections or severe heart disease.Check my eligibility

What is being tested?

The trial tests whether a sequence of stem cell transplantation (using αβ T-cell depletion) followed by a kidney transplant from the same donor can prevent organ rejection without lifelong immunosuppression drugs. It's an early-phase study at one center without randomization or control groups.See study design

What are the potential side effects?

Potential side effects include reactions to medications like ATG and Rituximab, risk of infection due to immune system suppression, complications from chemotherapy agents such as Melphalan and Fludarabine, and issues related to total body irradiation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My kidney function is moderately to severely reduced.

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I need a kidney transplant due to a specific genetic or immune disease, or because I rejected a previous transplant.

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I can make my own medical decisions or have someone legally authorized to do so for me.

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I am taking less than 0.5 mg/kg/day of steroids.

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My donor and I match for at least one allele at specific genetic markers.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ +1 year post-kt

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~+1 year post-kt

This trial's timeline: 3 weeks for screening, Varies for treatment, and +1 year post-kt for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic immunosuppression

Secondary outcome measures

Number of cases of secondary malignancies

Number of patients with acute GvHD

Number of patients with chronic GvHD

+6 more

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort 2a: Conditioning Regimen BExperimental Treatment8 Interventions

If the intervention is determined to be safe and non-futile, the study will continue to enroll eight more patients under Phase 2a following the same treatment as Phase 1b.

Group II: Cohort 2a: Conditioning Regimen AExperimental Treatment7 Interventions

If the intervention is determined to be safe and non-futile, the study will continue to enroll eight more patients under Phase 2a following the same treatment as Phase 1b.

Group III: Cohort 1b: Conditioning Regimen BExperimental Treatment8 Interventions

An initial cohort of 4 patients will be enrolled as part of the initial Phase 1b safety run-in evaluation. Patients will undergo an αβdepleted hematopoietic stem cell transplant (HSCT) after receiving conditioning regimen B (conditioning regimen type is dependent on underlying disease and not part of the experimental goals). In the presence of donor myeloid engraftment, at least 3 months post-HSCT, patients will undergo a living donor kidney transplant (KT) using same donor as HSCT. In the absence of any clinical signs of kidney rejection, pharmacological immunosuppression (used for KT) will be tapered off by Day +90 post-KT.

Group IV: Cohort 1b: Conditioning Regimen AExperimental Treatment7 Interventions

An initial cohort of 4 patients will be enrolled as part of the initial Phase 1b safety run-in evaluation. Patients will undergo an αβdepleted hematopoietic stem cell transplant (HSCT) after receiving conditioning regimen A (conditioning regimen type is dependent on underlying disease and not part of the experimental goals). In the presence of donor myeloid engraftment, at least 3 months post-HSCT, patients will undergo a living donor kidney transplant (KT) using same donor as HSCT. In the absence of any clinical signs of kidney rejection, pharmacological immunosuppression (used for KT) will be tapered off by Day +90 post-KT.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Melphalan

2008

Completed Phase 3

~1500

ATG

2016

Completed Phase 4

~1070

Rituximab

1999

Completed Phase 4

~1880

Fludarabine

2012

Completed Phase 3

~1100

Total Body Irradiation

2006

Completed Phase 3

~820

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Alice BertainaLead Sponsor

1 Previous Clinical Trials

154 Total Patients Enrolled

California Institute for Regenerative Medicine (CIRM)OTHER

64 Previous Clinical Trials

3,145 Total Patients Enrolled

1 Trials studying Cystinosis

6 Patients Enrolled for Cystinosis

Alice Bertaina, MDPrincipal InvestigatorStanford University

Media Library

ATG (Antibody) Clinical Trial Eligibility Overview. Trial Name: NCT05508009 — Phase 1 & 2

Cystinosis Research Study Groups: Cohort 1b: Conditioning Regimen B, Cohort 2a: Conditioning Regimen B, Cohort 1b: Conditioning Regimen A, Cohort 2a: Conditioning Regimen A

Cystinosis Clinical Trial 2023: ATG Highlights & Side Effects. Trial Name: NCT05508009 — Phase 1 & 2

ATG (Antibody) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05508009 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to partake in this clinical trial?

"This clinical trial is geared towards 12 individuals with chronic kidney disease, aged between 1 year and 30. To qualify for the study, participants must: be capable of giving informed consent or have a legal representative to provide it; practice effective contraception to prevent pregnancy throughout transplantation and immunosuppression if applicable; display a Lansky/Karnofsky score greater than 50 (the former applies to those under 16 years old); present with an underlying genetic/immunological condition such as SIOD, FSGS, cystinosis etc.; had previously rejected a kidney transplant regardless of origin; suffer from CKD stage 3+; possess"

Answered by AI

Are there any openings left to participate in this experiment?

"Per the clinicaltrials.gov records, this trial is no longer accepting enrolment as of August 17th 2022. It was initially posted on October 1st 2020 and has since concluded recruiting efforts; fortunately, there are 340 separate trials actively looking for volunteers at present time."

Answered by AI