EUCTR2022-000289-16-ATRecruitingPhase 1
A PHASE 3 RANDOMIZED CONTROLLED STUDY OF REACT IN PARTICIPANTS WITH TYPE 2 DIABETES AND CHRONIC KIDNEY DISEASE (REGEN-016)
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Sponsor
- ProKidney
- Enrollment
- 600
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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 44 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 8 weeks prior to screening 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 8 weeks prior to screening.
- •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.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 400
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 and within 12 weeks prior to Screening visit for any of the following tests (see protocol for full visits): 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.
- •7. 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.
- •8. The participant has a history of anaphylactic or severe systemic reaction(s) or
- •contraindication(s) to blood transfusions, Dextran-40, or bovine products.
- •9. 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 more than 15 cm from the skin surface to kidney capsule small kidneys (average size less than 9 cm) or has only one kidney.
- •10. The participant has a history of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
- •11. The participant has been diagnosed with acute kidney injury within 3 months of the Screening Visit.
- •12. 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.
- •13. 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.
- •14. 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).
- •15. ECG findings within 12 weeks before randomization that would
Investigators
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