Clinical trial • Phase II • Immunology

AT-1501 for Kidney transplant rejection

Phase II trial of AT-1501 for Kidney transplant rejection.

Overview

Trial Therapeutic Area
Immunology
Trial Disease
Kidney transplant rejection
Trial Stage
Phase II
Drug Modality
Monoclonal antibody | Small molecule

Key dates

Initial CTIS Submission Date
04-09-2024
First CTIS Authorization Date
08-01-2025

Trial design

open-label, tacrolimus (prograf) formulations listed as comparator: prograf 0.5 mg hard capsules, prograf 1 mg hard capsules, prograf 5 mg hard capsules (oral) and prograf 5 mg/ml concentrate for solution for infusion (iv). dosing/schedule for comparator arms not specified in the ctis record.-controlled Phase II trial in Spain, Germany, France.

Open Label
Yes
Comparator
Tacrolimus (Prograf) formulations listed as comparator: Prograf 0.5 mg hard capsules, Prograf 1 mg hard capsules, Prograf 5 mg hard capsules (oral) and Prograf 5 mg/ml concentrate for solution for infusion (IV). Dosing/schedule for comparator arms not specified in the CTIS record.
Target Sample Size
132
Trial Duration For Participant
1460

Eligibility

Recruits 132 Participants must continue to be able to understand the key components of the study as described in the written informed consent form and be willing and able to provide written informed consent. The CTIS record indicates isVulnerablePopulationSelected = false (no vulnerable populations selected)..

Pregnancy Exclusion
Pregnant or breastfeeding
Vulnerable Population
Participants must continue to be able to understand the key components of the study as described in the written informed consent form and be willing and able to provide written informed consent. The CTIS record indicates isVulnerablePopulationSelected = false (no vulnerable populations selected).

Inclusion criteria

  • {"criterion_text":"- A participant meeting the following criteria at the time of baseline will be considered for admission to the study: Successfully completed qualifying Parent study, where entry into the OLE was offered;"}
  • {"criterion_text":"- Continue to be able to understand the key components of the study as described in the written ICF, and is willing and able to provide written informed consent"}
  • {"criterion_text":"- Agree not to participate in another interventional study while on treatment"}
  • {"criterion_text":"- If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a pregnancy test is negative at baseline. Women of childbearing potential and men with partners that are of childbearing potential must agree to use highly effective methods of contraception from baseline through 120 days after the last administration of the study drug. Examples of acceptable methods of contraception are described in Table 6 and Table 7 (UK only)"}
  • {"criterion_text":"- If male, agree to use a medically accepted highly effective method of contraception and agree to use this method for 120 days after last administration of the study drug and agree to not donate sperm for 120days after last administration of the study drug"}

Exclusion criteria

  • {"criterion_text":"- A participant who meets any of the following criteria will be excluded from this study: Unwilling or unlikely to comply with the study requirements, in the opinion of the Investigator"}
  • {"criterion_text":"- Met any of the stopping criteria or discontinued study drug in the Parent study"}
  • {"criterion_text":"- Pregnant or breastfeeding"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Safety Endpoints: Incidence of treatment-emergent serious adverse events (TESAEs), treatment-emergent adverse events (TEAEs), and treatment-emergent AEs of special interest (AESIs).","definition_or_measurement_approach":"Measured as incidence counts of TESAEs, TEAEs and AESIs reported during treatment."}
  • {"endpoint_text":"- Changes in vital signs and clinical laboratory measures.","definition_or_measurement_approach":"Measured by clinical vital sign assessments and laboratory test results over time."}
  • {"endpoint_text":"- Kidney transplant medication side effects using the Modified Transplant Symptom Occurrence and Symptom Distress Scale (MTSOSD) at baseline and 12, 24, 36, and 48 months.","definition_or_measurement_approach":"Patient-reported MTSOSD instrument administered at baseline and at 12, 24, 36 and 48 months to assess symptom occurrence and distress."}

Secondary endpoints

  • {"endpoint_text":"- Efficacy endpoints: The proportion of participant and graft survival events at 12, 24, 36, and 48 months. Participant and graft survival events are defined as the earliest of either A) Death, B) Re-transplantation or C) Requirement for regular dialysis","definition_or_measurement_approach":"Proportion of participants meeting the composite survival event (death, re-transplantation, or need for regular dialysis) at specified timepoints."}
  • {"endpoint_text":"- The proportion of graft functional impairment at 12, 24, 36, and 48 months. A subject is considered to have graft functional impairment if they have an eGFR < 60 mL/min/1.73 m2","definition_or_measurement_approach":"Proportion of subjects with eGFR < 60 mL/min/1.73 m2 at specified timepoints."}
  • {"endpoint_text":"- The mean eGFR at 12, 24, 36, and 48 months","definition_or_measurement_approach":"Mean estimated glomerular filtration rate (eGFR) calculated at each specified timepoint."}
  • {"endpoint_text":"- Proportion of participants with BPAR at 12, 24, 36, and 48 months","definition_or_measurement_approach":"Proportion of participants with biopsy-proven acute rejection (BPAR) at specified timepoints."}
  • {"endpoint_text":"- Proportion of composite endpoint (graft failure, BPAR, or death) at 12, 24, 36, and 48 months","definition_or_measurement_approach":"Proportion of participants meeting the composite outcome of graft failure, BPAR, or death at specified timepoints."}

Recruitment

Planned Sample Size
132
Recruitment Window Months
59
Consent Approach
Participants must be willing and able to provide written informed consent; inclusion criteria require the participant to continue to understand the key components of the study and provide written informed consent. Subject information and informed consent forms are present in CTIS documents in French, German and Spanish (country-specific ICFs listed). No assent procedures for minors are indicated.

Geography

Total Number Of Sites
14
Total Number Of Participants
30

Spain

Earliest CTIS Part Ii Submission Date
27-09-2024
Latest Decision Or Authorization Date
08-01-2025
Processing Time Days
103
Number Of Sites
6
Number Of Participants
10

Sites

Site Name
Bellvitge University Hospital
Department Name
Nephrology
Principal Investigator Name
Edoardo Melilli
Principal Investigator Email
emelilli@bellvitgehospital.cat
Contact Person Name
Edoardo Melilli
Contact Person Email
emelilli@bellvitgehospital.cat
Site Name
Hospital Germans Trias I Pujol
Department Name
Nephrology
Principal Investigator Name
Anna Vila Santandreu
Principal Investigator Email
ANNAVILAS.GERMANSTRIAS@GENCAT.CAT
Contact Person Name
Anna Vila Santandreu
Site Name
Hospital Clinic De Barcelona
Department Name
Nephrology
Principal Investigator Name
Fritz Diekmann
Principal Investigator Email
fdiekman@clinic.cat
Contact Person Name
Fritz Diekmann
Contact Person Email
fdiekman@clinic.cat
Site Name
Hospital Del Mar
Department Name
Nephrology
Principal Investigator Name
Marta Crespo Barrio
Principal Investigator Email
mcrespo@psmar.cat
Contact Person Name
Marta Crespo Barrio
Contact Person Email
mcrespo@psmar.cat
Site Name
Hospital Universitari Vall D Hebron
Department Name
Nephrology
Principal Investigator Name
Oriol Bestard Matamoros
Principal Investigator Email
oriol.bestard@vallhebron.cat
Contact Person Name
Oriol Bestard Matamoros
Contact Person Email
oriol.bestard@vallhebron.cat

Germany

Earliest CTIS Part Ii Submission Date
09-12-2024
Latest Decision Or Authorization Date
09-01-2025
Processing Time Days
31
Number Of Sites
1
Number Of Participants
10

Sites

Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Nephrologie und Intensivmedizin
Principal Investigator Name
Klemens Budde
Principal Investigator Email
klemens.budde@charite.de
Contact Person Name
Klemens Budde
Contact Person Email
klemens.budde@charite.de

France

Earliest CTIS Part Ii Submission Date
11-11-2024
Latest Decision Or Authorization Date
10-01-2025
Processing Time Days
60
Number Of Sites
7
Number Of Participants
10

Sites

Site Name
Centre Hospitalier Regional Universitaire De Tours
Department Name
Nephrology– Hypertension– Kidney Transplantation
Principal Investigator Name
Philippe GATAULT
Principal Investigator Email
philippe.gatault@univ-tours.fr
Contact Person Name
Philippe GATAULT
Contact Person Email
philippe.gatault@univ-tours.fr
Site Name
Pellegrin Hospital
Department Name
Néphrologie, Transplantation rénale, Dialyse
Principal Investigator Name
Pierre MERVILLE
Principal Investigator Email
Pierre.merville@chu-bordeaux.fr
Contact Person Name
Pierre MERVILLE
Site Name
Centre Hospitalier Universitaire Grenoble Alpes
Department Name
Nephrology, Dialysis, Apheresis and Renal Transplantation
Principal Investigator Name
Lionel ROSTAING
Principal Investigator Email
lrostaing@chu-grenoble.fr
Contact Person Name
Lionel ROSTAING
Contact Person Email
lrostaing@chu-grenoble.fr
Site Name
Centre Hospitalier Et Universitaire De Limoges
Department Name
Néphrologie et Transplantation
Principal Investigator Name
Jean-Philippe REROLLE
Principal Investigator Email
Jean-philippe.rerolle@chu-limoges.fr
Contact Person Name
Jean-Philippe REROLLE
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Nephrology and Transplant Department
Principal Investigator Name
Antoine DURRBACH
Principal Investigator Email
antoine.durrbach@aphp.fr
Contact Person Name
Antoine DURRBACH
Contact Person Email
antoine.durrbach@aphp.fr
Site Name
Centre Hospitalier Universitaire Rouen
Department Name
Nephrology– Renal transplant
Principal Investigator Name
Dominique BERTRAND
Principal Investigator Email
dominique.bertrand@chu-rouen.fr
Contact Person Name
Dominique BERTRAND
Site Name
Centre Hospitalier Universitaire De Toulouse
Department Name
Nephrology and Organ Transplantation
Principal Investigator Name
Nassim KAMAR
Principal Investigator Email
Kamar.n@chu-toulouse.fr
Contact Person Name
Nassim KAMAR
Contact Person Email
Kamar.n@chu-toulouse.fr

Sponsor

Primary sponsor

Full Name
Eledon Pharmaceuticals Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
Icon Clinical Research Limited
Responsibilities
sponsorDuties codes: 1,10,11,12,13,3,4,5,6,9
Name
Celerion Inc.
Responsibilities
sponsorDuties codes: 4
Name
Scout Clinical
Responsibilities
Patient reimbursement services (sponsorDuties code: 15)
Name
CareDx Inc.
Responsibilities
sponsorDuties codes: 4

Third parties

  • {"country":"United States","full_name":"CareDx Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Industry"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient reimbursement services (sponsorDuties code: 15)","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Celerion Inc.","duties_or_roles":"sponsorDuties codes: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"sponsorDuties codes: 1,10,11,12,13,3,4,5,6,9","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
AT-1501 190 mg Vial
Active Substance
AT-1501
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
prodAuthStatus: 1
Starting Dose
20 mg/kg
Frequency
Baseline and every 3 weeks (up to 48 months; up to 64 infusions)
Maximum Dose
66.00 g (maxTotalDoseAmount as listed in product data)
Investigational Product Name
Prograf 0.5 mg hard capsules
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
prodAuthStatus: 2
Investigational Product Name
Prograf 1 mg hard capsules
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
prodAuthStatus: 2
Investigational Product Name
Prograf 5 mg hard capsules
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
ORAL
Route
Oral
Authorisation Status
prodAuthStatus: 2
Investigational Product Name
Prograf 5 mg/ml concentrate for solution for infusion
Active Substance
Tacrolimus
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
Intravenous
Authorisation Status
prodAuthStatus: 2
Combination Treatment
Yes

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