2. 1. Indications
2. Disease Overview
3. Mechanism of Action
4. Administration
5. Warnings
6. Patient resources
CONTENTS OF THIS PRESENTATION
3. Indications
Kerendia is a prescription medicine used in adults with chronic
kidney disease with associated type 2 diabetes to reuce the risk of:
Worsening of the kidney function
Kidney failure
Death due to cardiovascular disease
Heart attack
Hospitalization for heart failure
4. Clinical Data
In the renal outcomes trial (FIDELIO-DKD) of adult patients with
CKD associated with T2D
Kerendia significantly slowed CKD progression in addition to
an ACEi or ARB. The treatment effect reflected a reduction in
a sustained decline in eGFR of > 40% and progression to
kidney failure, or renal death
In the CV outcomes trial (FIGARO-DKD) the treatment effect
reflected a reduction of CV death, non-fatal MI, and
hospitalization for HF.
5. Kidney damage for ≥ 3 months as defined by: structural or
functional abnormality of kidney with or without decreased
GFR manifested by either pathologic abnormalities in
composition of blood or urine or abnormalities in imaging tests
OR:
GFR <60 ml/min/1.73m2 for 3 months with or without kidney
damage
Albuminuria :
Albuminuria refers to abnormal loss of albumin in urine
Albumin is one type of plasma protein in urine in normal
subjects and in larger quantity in patients with kidney damage
CKD
6. Classification of Albuminuria
Category Amount of albumin excreted
A1: Normal to mildly increased <30 mg/day (or mg/g)
A2: Moderately increased 30-300mg/day (or mg/g)
A3: Severely increased >300 mg/dl (or mg/g)
Nephrotic Syndrome >2,200 mg/day ( or mg/g)
7. Kerendia is a first-in-class nonsteroidal MR antagonist that blocks
MR overactivation. It blocks MR overactivation in tissues such as
kidneys, heart, and blood vessels.
Mechanism of Action:
8. Dosage and administration:
Kerendia is available as film-coated tablets and available in two strengths: 10 mg, 20
mg. Prior to Initiation of Kerendia check serum potassium levels and estimated
GFR, do not start the treatment if serum potassium is >5 mEq/L
Recommended Starting Dose:
10. Drug Interactions
Strong CYP3A4 inhibitor
Cocomitant use of Kerendia with Strong CYP3A4 is contradicted.
Avoid grapefruit or grapefruit juice
Moderate & weak CYP3A4 Inhibitors
Monitor serum potassium during drug initiation or dosage adjustment of either
Kerendia or weak CYP3A4i and adjust Kerendia dosage
Strong and Moderate CYP3A4 inducers
Avoid concomitant use of Kerendia with strong or moderta CYP3A4 inducers
11. Adverse effects:
In FDA trials:
Most common ADR: hyperkalemia, hypotension, hyponatremia
Serious adverse reactions occurred in 32% of patients receiving Kerenida and in
34% of patients receiving placebo. Permanent discontinuation due to adverse
reactions occurred in 7% of patients receiving Kerenida and in 6% of patients
receiving placebo. Hyperkalemia led to permanent discontinuation of treatment in
2.3% of patients receiving Kerendia versus 0.9% patients receiving placebo
In clinical use today: hyperkalemia, hypotension, and
hyponatremia are still the most common adverse effects
12. WARNINGS AND PRECAUTIONS:
HYPERKALEMIA:
Kerendia can cause hyperkalemia. The risk for
developing hyperkalemia increases with decreasing
kidney function
Do not initiate Kerendia if serum potassium is >5 mEq/L
Measure serum potassium periodically during treatment
with Kerendia and adjust dose accordingly
Kerendia is a non-steroidal mineralocorticoid receptor antagonist. It is proven to slow the progression of CKD in adults with T2D that could lead to kidney failure, dialysis, or tx.
Two large studies have looked at the effects of Kerendia in patients with T2D and CKD. The first study (FIDELIO-DKD) looked at kidney disease outcomes and second study (FIGARO-DKD) evaluated cardiovascular outcomes.
CKD in T2D is a progressive disease which means it cannot be cured and the damage to your kidneys cannot be revered. CKD in T2D often has no symptoms until you reach later stages of CKD.
To understand how Kerendia works, it helps to understand why CKD in T2D may progress over time. There are 3 main factors that contribute to the progression of CKD.
Poorly controlled BG
Poorly controlled BP
Inflammation and scarring in the kidney, While diabetes/HTN meds can control to manage your BG and HTN. Kerendia is the only medication that blocks the overactivation in kidneys, heat and blood vessels. Mineral corticoid overactivation can lead to inflammation and scarring of the tissue lead to CKD, CVD
