Not Yet RecruitingPhase 3ACTRN12625001170415

The FAME 2 Kidney trial is a study of whether fenofibrate is able to slow kidney disease progression in adults with type 2 diabetes with moderate kidney damage

The Fenofibrate And Microvascular Events in Type 2 diabetes Kidney Trial (FAME 2 Kidney): A multicentre, randomised, double-blind, placebo-controlled phase 3b trial to determine whether oral fenofibrate is able to slow the progression of stage 3 kidney disease in adults with type 2 diabetes.

Sponsor

Baker Heart & Diabetes Research Insitute

Enrollment

1,000 participants

Start Date

Dec 1, 2025

Study Type

Interventional

Conditions

Diabetes Type 2

Summary

The FAME 2 Kidney study is a large international clinical trial testing whether a low-cost, once-daily medication called fenofibrate can slow kidney damage in people with type 2 diabetes and moderate chronic kidney disease. Researchers believe fenofibrate may help protect kidney function and reduce other diabetes-related complications, compared to a placebo.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria17

In order to be eligible for this study, an individual must meet all of the following criteria:
Are willing and able to give signed and dated written informed consent before initiation of any study-related procedures.
Available and willing to comply with required study procedures for the trial duration.
Male or female, aged equal or more than 18 years at Visit 1.
a. Females may be enrolled if all 3 of the following criteria are met:
i. They are not pregnant.
ii. They are not breastfeeding.
iii. They do not plan on becoming pregnant during the trial.
b. Women of child-bearing potential (WOCP) must have a negative pregnancy test at Visit One
i. Definition of WOCP: all those who have NOT had a hysterectomy or bilateral tubal ligation or bilateral ovariectomy at a minimum of 1 cycle prior to signing the consent form for this trial OR who are NOT post-menopausal.
ii. Definition of post-menopausal: women greater than or equal to 55 years and equal to or more than 1 year from the last menstrual period, OR women less than 55 years and 1 year or more from the last menstrual period and FSH in the post-menopausal range of 40 mIU/mL at Visit one..
c. Women of child-bearing potential must practice an acceptable method of birth-control and continue using this method throughout the study and for 35 days after end of treatment and agree to submit to periodic pregnancy testing during participation in the trial.
Diagnosed with type 2 diabetes, as per criteria of the American Diabetes Association “Diagnosis and Classification of Diabetes: Standards of Care in Diabetes—2024”.
eGFR 30 - 59 mL/min/1.73 m2 inclusive, calculated by CKD-EPI creatinine 2021 formula based on at Visit 1.
There are no restrictions on entry levels of HbA1c, BMI or blood pressure or albuminuria at Visit 1.
There are no restrictions on type of non-fibrate lipid-lowering medication or type of diabetes medication, or duration of treatment with these agents prior to Visit 1.
There are no restrictions on use of other (non-experimental) blood pressure or glucose control drugs. Participants can be prescribed by their usual clinicians’ drugs including RAAS drugs, SLT2 inhibitors and GLP-1 agonists and metformin.

Exclusion Criteria22

Type 1 diabetes or LADA
Known contraindication to fenofibrate or the excipients in the tablet.
Any definite indication for fenofibrate (or other fibrate) in the opinion of the investigator.
Fasting triglyceride level at Visit 1 > 6.5 mmol/L as this level of hypertriglyceridaemia usually requires fenofibrate treatment.
Known hypersensitivity to any fibrate drug, or history of photosensitivity rash or myopathy/myositis.
Liver disease, defined as cirrhosis or Child-Pugh class B or C, or serum levels of transaminase (ALT or AST) >3 x the upper limit of normal (ULN) at Visit 1, or total bilirubin >2 x the ULN measured at Visit 1 (except for documented Gilbert’s disease).
Chronic active hepatitis B or C or known infection with HIV. Participants with documented hepatitis C eradication (after treatment) are allowed.
Unexplained creatine kinase (CK) levels > ULN at Visit 1.
Known active gallbladder disease at Visit 1.
Known significant non-diabetic renal disease. Concomitant hypertension with diabetes is allowed, and its treatment by their usual clinicians recommended.
eGFR < 20 ml/min/1.72m2 at Run In response visit
Dialysis for acute kidney injury within 12 weeks prior to Visit 1.
Previous pancreatitis, DVT or pulmonary embolism.
History of an active or untreated malignancy, or in remission from a clinically significant malignancy (other than keratinocyte skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer or other low risk malignancy) for less than 2 years prior to Visit 1 or are receiving or planning to receive therapy for cancer, at Visit 1. The site PI can seek advice via the trial co-ordinating centre.
Untreated or under-treated hypothyroidism (TSH > 1.5 x ULN or FT4 <lower limit of normal) or hyperthyroidism. Stable treated thyroid disease for at least 4 weeks prior to Visit 1 is permitted.
17. Anaemia: Hb less than 9.0 g/dL despite treatment. (Rescreening is permissible once)
Alcohol or drug abuse within the 3-months prior to Visit 1.
Recent unstable medical or surgical condition in last 3 months, including diabetic ketoacidosis, hyperosmolar hyperglycaemic state, lactic acidosis or sepsis.
Recent CVD event (e.g. AMI, unstable angina, stroke or hospitalisation for heart failure) within 6-months from Visit 1.
Prior organ transplant or any condition other than end stage kidney disease that is likely to lead to organ transplantation in the next 5 years.
History of hereditary problems of galactose intolerance, lactase deficiency, or glucose-galactose malabsorption.
Any condition, other than vascular disease, with life expectancy < 5 years, which might prevent participation for the full planned study period.

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Interventions

The study has two parts- a run-in period followed by the main study. The run-in period lasts for 6-weeks. During this time, participants will be asked at take a tablet daily, however, participants w

The study has two parts- a run-in period followed by the main study. The run-in period lasts for 6-weeks. During this time, participants will be asked at take a tablet daily, however, participants will not be told if they are receiving fenofibrate or an inactive tablet. After successful completion of the run-in period, participants will be randomly assigned to receive either oral fenofibrate 145 mg once daily or a matching placebo tablet. for 3 .5 years. Successful completion of the run-in period will be determined by eGFR parameters (as a measure of kidney function) and participant medication compliance. Participants will be asked to attend for 6 monthly visits which should be timed to occur at the times of scheduled routine care visits when possible. Some of these visits may be performed via telehealth. All participants will undergo an End of Treatment visit upon cessation of the study drug followed by an 8-week washout period and final end of study visit. The study will assess the impact of fenofibrate on the progression of stage 3 kidney chronic kidney disease (CKD) in adults with type 2 diabetes (T2D), using estimated glomerular filtration rate (eGFR) slope and other renal, cardiovascular and microvascular endpoints.