FINESSE: Research on improving albuminuria in patients with chronic kidney disease through the use of finerenone and semaglutide.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Universitair Medisch Centrum Groningen

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

Trial duration

11 Feb 2025 → ongoing

Decision date (initial)

2024-04-30

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

Diabetes Fonds

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Safety, Therapy

The primary objective is to demonstrate that at least 30% albuminuria reduction can be achieved in a substantial proportion of patients with a single drug (MRA finerenone or GLP1-RA semaglutide) when the best drug for each patient is selected.

Secondary objectives 2

1. Combination treatment with finerenone and semaglutide further lowers albuminuria at a population level but will only marginally improve the portion of patients with a 30% reduction in albuminuria when the best drug for each patient is selected.
2. The monitoring of an individual’s drug response and selection of the right drug for each patient can be performed remotely (i.e. at home).

Conditions and MedDRA coding

Chronic Kidney Disease

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 7

1. Age ≥ 18 years
2. Urinary albumin to creatinine ratio ≥100 mg/g and ≤3500 mg/g
3. eGFR ≥25 and ≤90 mL/min/1.73m2
4. HbA1c ≥5.7% and <11%
5. On a stable dose of an ACEi/ARB for at least 4 weeks if tolerated
6. On a stable dose of a SGLT2 inhibitor for at least 4 weeks if tolerated
7. Willing to sign an informed consent

Exclusion criteria 24

1. Diagnosis of type 1 diabetes
2. History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening or according to investigator’s assessment.
3. History of noncompliance to medical regimens or unwillingness to comply with the study protocol.
4. Heart Failure with reduced ejection fraction and NYHA Class II to IV
5. Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.
6. Women of childbearing potential (WOCBP): WOCBP who are unwilling or unable to use an acceptable method of contraception to avoid pregnancy throughout the study and for up to 8 weeks after the last dose of study drug in such a manner the risk of pregnancy is minimized; WOCBP must have a negative serum or urine pregnancy test result (minimum sensitivity 25 IU/L or equivalent of HCG) at screening.
7. Acute coronary syndrome event within 6 months
8. Serum potassium > 5.0 mmol/L
9. Evidence of severe hepatic impairment determined by any one of: ALT or AST values exceeding 3x ULN, a history of hepatic encephalopathy, a history of oesophageal varices, or a history of portocaval shunt
10. Active pregnancy or breastfeeding
11. History of kidney or liver transplant
12. History of chronic pancreatitis or idiopathic acute pancreatitis
13. Active malignancy
14. Suggestive evidence of adrenal insufficiency
15. Heart Failure with reduced ejection fraction
16. Use of any of the following medications: CYP3A4 inhibitors, potassium sparing medications, trimethoprim, trimethoprim/sulfamethoxazole, GLP-1 RAs, and potassium supplements.
17. Personal or family history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma
18. Personal history of non-familial medullary thyroid carcinoma
19. History of severe hypersensitivity or contraindications to any MRA or GLP-1 RA
20. Uncontrolled arterial hypertension (mean sitting systolic blood pressure (SBP) ≥180 mmHg or diastolic blood pressure (DBP) ≥110 mmHg)
21. Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the 6 months; Major gastrointestinal tract surgery as determined by the physician; Pancreatitis within 6 months. GI ulcers and/or bleeding within 6 months; Evidence of urinary obstruction or difficulty in voiding at screening.
22. Participation in any clinical trial within 3 months prior to initial dosing.
23. Donation or loss of ≧400 ml blood within 8 weeks prior to initial dosing.
24. • Vulnerable (i.e. under guardianship) or mentally incapacitated subjects (i.e. not able to understand and sign the informed consent)

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Endpoint parameter is the percentage change from baseline in UACR.

Secondary endpoints 2

1. Percentage change from baseline in UACR.
2. Number of missed urine collection in the remote (@home) setting

Investigational products

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

Test 4

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Universitair Medisch Centrum Groningen

Sponsor organisation

Universitair Medisch Centrum Groningen

Address

Hanzeplein 1

City

Groningen

Postcode

9713 GZ

Country

Netherlands

Scientific contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Hiddo Lambers-Heerspink

Public contact point

Organisation

Universitair Medisch Centrum Groningen

Contact name

Hiddo Lambers-Heerspink

Third parties 1

Locations

4 EU/EEA countries · 7 investigational sites

By country

Investigational sites

Country notifications

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

Application history

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