Kidney ABC

Overview

Sponsor-declared trial summary

Key facts

Sponsor

River 3 Renal Corp.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18], Diseases [C] - Pathological Conditions, Signs and Symptoms [C23]

Trial duration

9 Oct 2024 → ongoing

Decision date (initial)

2024-07-11

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacokinetic, Efficacy

To evaluate the efficacy of R3R01 in reducing albuminuria at 12 weeks (Day 84)
when compared to placebo.

Secondary objectives 2

1. To evaluate the efficacy of R3R01 on eGFR at 12 weeks (Day 84) compared to placebo.
2. To evaluate the pharmacokinetics of R3R01 in subjects with DKD and compare the pharmacokinetics to subjects with AS or FSGS.

Conditions and MedDRA coding

Diabetic kidney disease

Regulatory references

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Male or female adults (above 18 years) with type 2 diabetes (controlled with hemoglobin A1c <10.5%).
2. Stable antihypertensive treatment 4 weeks before start of study drug and throughout study duration.
3. Titrated to the maximal dose or maximal tolerated dose of renin-angiotensin blocking treatment.
4. Stable treatment with lipid lowering agents for at least 4 weeks.
5. People on SGLT2-Inhibitors should be on stable dose of the drug for at least 3 months
6. UACR >30 mg/g and < 5000 mg/g on two consecutive measurements
7. eGFR >30 ml/min/1.73 m2 (CKD-EPI formula)
8. 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.
9. Systolic blood pressure ≥110 mmHg and ≤160 mmHg.
10. 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)
11. 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

Exclusion criteria 12

1. Polycystic kidney disease, ANCA-associated vasculitis or lupus nephritis
2. Ongoing cancer treatment
3. Immunosuppressive therapy or immunosuppression in the prior 6 months
4. Nephrotic syndrome
5. Impaired liver function (clinically significant)
6. Pregnancy or lactation
7. Failure to understand patient information or to collaborate with the investigator
8. 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
9. History of hypersensitivity to study drug and/or any of its excipients
10. Hereditary galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
11. Active or planned treatment with a medication that interacts with R3R01
12. 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.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Urinary albumin-to-creatinine ratio (UACR) (Change from randomization to end of treatment at 3 months)

Secondary endpoints 3

1. Measured GFR with plasma clearance of 99Tc-DTPA or eGFR measured with the CKD-EPI equation based on creatinine and/or cystatin C
2. 24 hours ambulatory blood pressure
3. Plasma PK parameters of R3R01

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

River 3 Renal Corp.

Sponsor organisation

River 3 Renal Corp.

Address

7550 Purple Sage

City

Park City

Postcode

84098-5557

Country

United States

Scientific contact point

Organisation

River 3 Renal Corp.

Contact name

Chief Medical Officer

Public contact point

Organisation

River 3 Renal Corp.

Contact name

Clinical Operations Director

Third parties 5

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 14 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

6 submissions — initial application plus substantial / non-substantial modifications