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    Summary
    EudraCT Number:2022-000289-16
    Sponsor's Protocol Code Number:REGEN-016
    National Competent Authority:Portugal - INFARMED
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2023-04-13
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedPortugal - INFARMED
    A.2EudraCT number2022-000289-16
    A.3Full title of the trial
    A PHASE 3 RANDOMIZED CONTROLLED STUDY OF REACT IN PARTICIPANTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (REGEN-016)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants receiving institutional standard of care will undergo scripted sham procedures (scripted sham biopsy and 2 scripted sham REACT injections). Cohort 2 participants receiving institutional standard of care will receive 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months apart (+30 days)
    A.4.1Sponsor's protocol code numberREGEN-016
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorProKidney
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportProKidney
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationProKidney
    B.5.2Functional name of contact pointProKidney Clinical
    B.5.3 Address:
    B.5.3.1Street Address8020 Arco Corporate Dr. Ste 400
    B.5.3.2Town/ cityRaleigh North Carolina
    B.5.3.3Post code27617
    B.5.3.4CountryUnited States
    B.5.4Telephone number001336448 2843
    B.5.6E-mailinfo@prokidney.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRenal Autologous Cell Therapy (REACT)
    D.3.2Product code 16482
    D.3.4Pharmaceutical form Suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPRoute of administration not applicable
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRilparencel
    D.3.9.3Other descriptive nameREACT/NKA
    D.3.9.4EV Substance CodeSUB217615
    D.3.10 Strength
    D.3.10.1Concentration unit Other
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100E6
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product Yes
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Yes
    D.3.11.3.5.1CAT classification and reference numberTissue Engineered Product EMA/CAT/361680/2021
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
    E.1.1.1Medical condition in easily understood language
    TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE
    E.1.1.2Therapeutic area Body processes [G] - Physiological processes [G07]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 23.1
    E.1.2Level PT
    E.1.2Classification code 10064848
    E.1.2Term Chronic kidney disease
    E.1.2System Organ Class 10038359 - Renal and urinary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of up to 2 REACT injections given 3 months apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function in participants with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD).
    E.2.2Secondary objectives of the trial
    To assess the efficacy of up to 2 REACT injections given 3 months apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function in participants with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Unless otherwise noted, participants must satisfy each inclusion criterion to participate in the study. Inclusion criteria will be assessed at the Screening Visit.
    1. The participant is male or female, 30 to 80 years of age on the date of informed consent.
    2. The participant has a clinical diagnosis of T2DM in their health record.
    3. The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
    4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
    5. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m2, not requiring renal dialysis.
    6. The participant has a urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.
    7. The participant has stable blood pressure and is maintained on a stable antihypertensive medication regimen if treatment for hypertension is necessary. If treatment contains an angiotensin converting enzyme inhibitor (ACEI) or an angiotensin receptor blocker (ARB), that treatment must be the maximum tolerated daily dose for at least 4 weeks prior to randomization or if the treatment includes a sodium glucose cotransporter 2 inhibitor (SGLT2i) or mineralocorticoid receptor antagonists (MRA) at any dose, is stable for at least 4 weeks prior to randomization.
    8. The participant agrees and is able to refrain from nonsteroidal anti-inflammatory drugs (NSAIDs), including aspirin, and clopidogrel, prasugrel, dipyridamole, or other platelet aggregation inhibitors during the period beginning 7 days before through 7 days following the percutaneous renal biopsy and REACT injection(s).
    9. The participant agrees and is able to refrain from oral ingestion of fish oil supplements during the period beginning 7 days before through 7 days following the percutaneous renal biopsy and REACT injection(s).
    10. The participant is willing and able to cooperate with all aspects of the protocol.
    11. The participant is willing and able to provide signed informed consent.
    E.4Principal exclusion criteria
    Participants who satisfy any exclusion criterion listed below are not eligible to participate in the study. Exclusion criteria will be assessed at the Screening Visit.
    1.The participant has a history of type 1 diabetes mellitus.
    2.The participant has a history of renal transplantation.
    3. The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated.
    4. The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.
    5. The participant appears to be at possibly increased risk of either thromboembolism or bleeding because of abnormal results at the Screening Visit for any of the following tests: activated partial thromboplastin time (APTT), prothrombin time-international normalized ratio (PT-INR), and platelet count.
    6. The participant has a bleeding disorder(s) or is maintained on any anticoagulant agents, including fractionated heparin preparations, Coumadin® (warfarin), or direct thrombin inhibitors that cannot be discontinued for 7 days before and 7 days after biopsy or injections. The participant has a known allergy or contraindication(s), has experienced severe systemic reaction(s), to kanamycin/structurally similar aminoglycoside antibiotic(s), which may be a manufacturing process residual, or has a known hypersensitivity to dimethyl sulfoxide.
    7. The participant has a history of anaphylactic or severe systemic reaction(s) or
    contraindication(s) to blood transfusions, Dextran-40, or bovine products.
    8. The participant is not a good candidate to undergo percutaneous REACT injection, in the judgment of the proceduralist or physician who will perform the procedure. This includes confirming the participant has contraindications for undergoing the procedure based on depth of the kidney, positioning limitations, body habitus and if the kidney is >15 cm from the skin surface to kidney capsule, or has only one kidney.
    9. The participant has a history of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
    10. The participant has been diagnosed with acute kidney injury within 3 months of the Screening Visit.
    11. The participant has any of the following conditions: Autosomal dominant and recessive polycystic kidney disease, focal segmental glomerulosclerosis, vasculitis related CKD, IgA nephropathy and other immune modulated nephropathies, drug-induced or hypertension related CKD and other types of CKD or anatomic variants as determined by the Principal Investigator that would interfere with biopsy and REACT injection procedure (such as horseshoe kidney variant and unexplained hydronephrosis), any other documented renal pathology that would interfere with the REACT injection procedure.
    12. Myocardial infarction, unstable angina, revascularization procedure (e.g. stent or bypass graft surgery), or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
    13. Current or history of heart failure of New York Heart Association (NYHA) Class IV
    cardiac disease (The Criteria Committee of the New York Heart Association).
    14. ECG findings within 12 weeks before randomization that would require urgent diagnostic evaluation or intervention (e.g., new clinically important arrhythmia or conduction disturbance).
    15. The participant has a history of malignancy within the past 3 years (exceptions: basal cell carcinomas of the skin and carcinoma of the cervix in situ, or a malignancy that in the opinion of the Investigator, along with the Medical Monitor, is considered treated with minimal risk of recurrence).
    16. The participant has documented clinical diagnosis of chronic hepatic disease (alanine aminotransferase [ALT] or aspartate aminotransferase [AST] greater than 3 times the upper limit of normal) at the Screening Visit.
    17. The participant has a positive test for the Hepatitis B surface antigen, a positive test for Hepatitis C antibodies, a positive test for Human Immunodeficiency Virus antibodies, or a positive test for an active syphilis infection.
    18. The participant has a documented clinical diagnosis of active tuberculosis (TB) requiring treatment.
    19. The participant is immunocompromised or is receiving immunosuppressive agents,
    including individuals treated for chronic glomerulonephritis within 3 months of the
    Screening Visit.
    Please refer to the protocol for more details
    E.5 End points
    E.5.1Primary end point(s)
    The time from first injection to the earliest of:
    • At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
    • eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or
    • Renal or cardiovascular death.
    E.5.1.1Timepoint(s) of evaluation of this end point
    As per the protocol
    E.5.2Secondary end point(s)
    The time from first injection to the earliest of:
    • At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or
    • eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or
    • Increase of UACR of at least 30% and of at least 30 mg/g using the random urine microalbumin/urine creatinine ratio sustained for 90 days or
    • Renal or cardiovascular death.
    E.5.2.1Timepoint(s) of evaluation of this end point
    As per the protocol
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    scripted sham-controlled intervention study
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    scripted sham-controlled intervention study
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA43
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Brazil
    Chile
    Colombia
    India
    Malaysia
    New Zealand
    Singapore
    Thailand
    Turkey
    Serbia
    Austria
    Belgium
    Denmark
    France
    Germany
    Ireland
    Italy
    Portugal
    Spain
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the time when the last participant completes the EOS Visit, or when the last participant is considered lost to follow-up, withdraws consent, or dies.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 400
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state19
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 212
    F.4.2.2In the whole clinical trial 600
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients will be encouraged to enrol in a long term follow protocol which will follow patients for an additional 36 months.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation IMI, SA - Imagens Médicas Integradas
    G.4.3.4Network Country Portugal
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2023-06-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-05-26
    P. End of Trial
    P.End of Trial StatusOngoing
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