R3R01 for Diabetic kidney disease

Inclusion criteria

• {"criterion_text":"- Male or female adults (above 18 years) with type 2 diabetes (controlled with hemoglobin A1c <10.5%)."}
• {"criterion_text":"- Both female patients, as well as female partners of male patients who are of childbearing potential must be willing to not become pregnant for the complete duration of the study (>180 days) (90 days after the last dose of study medication)"}
• {"criterion_text":"- Males (including sterilized subjects) whose female partners have child-bearing potential, must agree to use male contraception (condoms) during the period from the time of signing the informed consent form (ICF) through 90 days after the last dose of study drug. They must agree to immediately inform the investigator if their partner becomes pregnant during the study"}
• {"criterion_text":"- Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration."}
• {"criterion_text":"- Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blocking treatment."}
• {"criterion_text":"- Stable treatment with lipid lowering agents for at least 4 weeks."}
• {"criterion_text":"- People on SGLT2-Inhibitors should be on stable dose of the drug for at least 3 months"}
• {"criterion_text":"- UACR >30 mg/g and < 5000 mg/g on two consecutive measurements"}
• {"criterion_text":"- eGFR >30 ml/min/1.73 m2 (CKD-EPI formula)"}
• {"criterion_text":"- Abdominal obesity (Waist circumference) Women: > 80 cm, Men: > 95 cm or fasting triglyceride >2.0 mmol/l based on historic laboratory values within 2 years before screening."}
• {"criterion_text":"- Systolic blood pressure ≥110 mmHg and ≤160 mmHg."}

Exclusion criteria

• {"criterion_text":"- Polycystic kidney disease, ANCA-associated vasculitis or lupus nephritis"}
• {"criterion_text":"- Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption"}
• {"criterion_text":"- Active or planned treatment with a medication that interacts with R3R01"}
• {"criterion_text":"- Any other medical condition(s) that might put the patient at risk or influence study results in the investigators opinion, or that the investigator deems unsuitable for the study including drug or alcohol abuse or psychiatric, behavioral, or cognitive disorders sufficient to interfere with the patient’s ability to understand and comply with the protocol instructions or follow-up procedures."}
• {"criterion_text":"- Ongoing cancer treatment"}
• {"criterion_text":"- Immunosuppressive therapy or immunosuppression in the prior 6 months"}
• {"criterion_text":"- Nephrotic syndrome"}
• {"criterion_text":"- Impaired liver function (clinically significant)"}
• {"criterion_text":"- Pregnancy or lactation"}
• {"criterion_text":"- Failure to understand patient information or to collaborate with the investigator"}
• {"criterion_text":"- Females of childbearing potential (those who are not surgically sterilized or post-menopausal for at least 1 year) are excluded from participation in the study unless they agree to use highly effective contraception"}
• {"criterion_text":"- History of hypersensitivity to study drug and/or any of its excipients"}

Primary endpoints

• {"endpoint_text":"- Urinary albumin-to-creatinine ratio (UACR) (Change from randomization to end of treatment at 3 months)","definition_or_measurement_approach":"Change from randomization to end of treatment at 3 months in urinary albumin-to-creatinine ratio (UACR)."}

Secondary endpoints

• {"endpoint_text":"- Measured GFR with plasma clearance of 99Tc-DTPA or eGFR measured with the CKD-EPI equation based on creatinine and/or cystatin C","definition_or_measurement_approach":"Measured GFR by plasma clearance of 99Tc-DTPA or estimated GFR using the CKD-EPI equation based on creatinine and/or cystatin C."}
• {"endpoint_text":"- 24 hours ambulatory blood pressure","definition_or_measurement_approach":"24-hour ambulatory blood pressure monitoring."}
• {"endpoint_text":"- Plasma PK parameters of R3R01","definition_or_measurement_approach":"Pharmacokinetic parameters measured in plasma for R3R01 (unspecified parameters listed as plasma PK parameters)."}

Methods

• Introductory letter (Danish) — document: K2_Recruitment material_Intro Letter in Danish_For publication (channel: printed letter; language: Danish)
• Announcement text — document: K2_Recruitment material_Announcement text_For publication (channel: announcement text; language: Danish)
• Announcement / trial tree — document: K2_Recruitment material_Announcement trial tree_For publication (channel: illustrative/flow materials; language: Danish)
• Introductory letter NOH (redacted) — document: K2_Introduktionsbrev_NOH_Redacted (channel: letter; language: Danish)
• Social media posts — document: K2_Social Media Posts_Redacted (channel: social media)

Denmark

Earliest CTIS Part Ii Submission Date

01-07-2024

Latest Decision Or Authorization Date

28-04-2026

Processing Time Days

667

Number Of Sites

1

Number Of Participants

60

Primary sponsor

Full Name

River 3 Renal Corp.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Iqvia Biotech Limited

Responsibilities

codes 6, 7

Third parties

• {"country":"Italy","full_name":"Arithmos S.r.l.","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Iqvia Biotech Limited","duties_or_roles":"codes 6, 7","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Lumis Life Science Consulting GmbH","duties_or_roles":"codes 1, 12","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Q2 Solutions LLC","duties_or_roles":"code 4","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"code 14","organisation_type":"Hospital/Clinic/Other health care facility"}