Watch Dr Brunton
and Dr Wright discuss
a patient case
When people with T2D develop CKD, they head down a dangerous path1
Meet 3 patients who could benefit from KERENDIA4
Patients with progressing CKD associated with T2D need your help at every stage of their journey
Kevin, 57 years old4
Works full time and has an active social life. He was diagnosed with T2D 8 years ago, which has led to CKD.
Declining eGFR:58 mL/min/1.73 m2
Microalbuminuria*
Current therapy: Taking multiple T2D
standard-of-care medications,† including
an optimized dose of an ARB
*Microalbuminuria can be defined as "moderately increased" with a UACR of 30-300 mg/g.5
†In the FIDELIO-DKD trial, approximately 97% of patients were on an antidiabetic medication
(insulin [64.1%], biguanides [44%], GLP-1 receptor agonists [7%] and/or SGLT2 inhibitor [5%]).
Background therapies were similar in the FIGARO-DKD trial.4
Kevin, 57 years old4
Works full time and has an active social life. He was diagnosed with T2D 8 years ago, which has led to CKD.
Declining eGFR:58 mL/min/1.73 m2
Microalbuminuria*
Current therapy: Taking multiple T2D standard-of-care medications,† including an optimized dose of an ARB
*Microalbuminuria can be defined as "moderately
increased" with a UACR of 30-300 mg/g.5
†In the FIDELIO-DKD trial, approximately 97% of patients
were on an antidiabetic medication (insulin [64.1%],
biguanides [44%], GLP -1 receptor agonists [7%] and/or
SGLT2 inhibitor [5%]). Background therapies were
similar in the FIGARO-DKD trial.4
Assessing both UACR and eGFR can detect risk of CKD progression earlier5
Assess Kevin's risk of CKD progression
Risk of CKD progression based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013; 3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Risk of CKD progression based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
eGFR categories: eGFR ≥90 mL/min/1.73 m2=normal or high (G1); eGFR 60–89 mL/min/1.73 m2=mildly decreased (G2); eGFR 45–59 mL/min/1.73 m2=mildly to moderately decreased (G3a); eGFR 30–44 mL/min/1.73 m2= moderately to severely decreased (G3b); eGFR 15–29 mL/min/1.73 m2=severely decreased (G4); eGFR <15 mL/min/1.73 m2=kidney failure (G5).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013; 3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Ken, 62 years old4
Former smoker who had an MI 2 years ago. He was diagnosed with T2D 10 years ago, which has led to his recent diagnosis of CKD.
eGFR:57 mL/min/1.73 m2
Albuminuria/UACR:360 mg/g
BP and HbA1c:Treated for individualized goal
Serum potassium: 4.2 mEq/L
Current therapy: Maximum tolerated
labeled dose of an ACEi, T2D standard of care,*
aspirin monotherapy, and a statin
*In the FIDELIO-DKD trial, approximately 97% of patients were on an antidiabetic medication (insulin [64.1%], biguanides [44%], GLP-1 receptor agonists [7%], and/or SGLT2 inhibitors [5%]). Background therapies were similar in the FIGARO-DKD trial4
Ken, 62 years old4
Former smoker who had an MI 2 years ago. He was diagnosed with T2D 10 years ago, which has led to his recent diagnosis of CKD.
eGFR: 57 mL/min/1.73 m2
Albuminuria/UACR: 360 mg/g
BP and HbA1c: Treated for individualized goal
Serum potassium: 4.2 mEq/L
Current therapy: Maximum tolerated labeled dose of an ACEi, T2D standard of care,* aspirin monotherapy, and a statin
*In the FIDELIO-DKD trial, approximately 97% of patients
were on an antidiabetic medication (insulin [64.1%],
biguanides [44%], GLP-1 receptor agonists [7%], and/or
SGLT2 inhibitors [5%]). Background therapies were
similar in the FIGARO-DKD trial4
Patients with high albuminuria are more likely to die from a CV event than patients with normal albumin levels5,6
Risk of CV mortality based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013;3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Risk of CV mortality based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013; 3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
eGFR alone shows an incomplete picture of your patients' risk of CKD progression5
Risk of CKD progression based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013; 3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Risk of CKD progression based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
eGFR categories: eGFR ≥90 mL/min/1.73 m2=normal or high (G1); eGFR 60–89 mL/min/1.73 m2=mildly decreased (G2); eGFR 45–59 mL/min/1.73 m2=mildly to moderately decreased (G3a); eGFR 30–44 mL/min/1.73 m2= moderately to severely decreased (G3b); eGFR 15–29 mL/min/1.73 m2=severely decreased (G4); eGFR <15 mL/min/1.73 m2=kidney failure (G5).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013; 3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Kathy, 65 years old4,5
Full-time social worker who enjoys watching musicals with her husband and granddaughter. She has been diagnosed with CKD associated with T2D.
Declining eGFR:44 mL/min/1.73 m2
Albuminuria/UACR: >300 mg/g
Current therapy: T2D standard of care,*
maximum tolerated dose of an ARB
*In the FIDELIO-DKD trial, approximately 97% of patients were on an antidiabetic medication
(insulin [64.1%], biguanides [44%], GLP-1 receptor agonists [7%], and/or SGLT2 inhibitors [5%]).
Background therapies were similar in the FIGARO-DKD trial.4
Kathy, 65 years old4,5
Full-time social worker who enjoys watching musicals with her husband and granddaughter. She has been diagnosed with CKD associated with T2D.
Declining eGFR:44 mL/min/1.73 m2
Albuminuria/UACR:>300 mg/g
Current therapy: T2D standard of care,* maximum tolerated dose of an ARB
*In the FIDELIO-DKD trial, approximately 97% of patients
were on an antidiabetic medication (insulin [64.1%],
biguanides [44%], GLP-1 receptor agonists [7%], and/or
SGLT2 inhibitors [5%]). Background therapies were
similar in the FIGARO-DKD trial.4
Kathy's UACR and eGFR level put her at very high risk, but there is still time to intervene5
Risk of CKD progression based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013;3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Risk of CKD progression based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
eGFR categories: eGFR ≥90 mL/min/1.73 m2=normal or high (G1); eGFR 60–89 mL/min/1.73 m2=mildly decreased (G2); eGFR 45–59 mL/min/1.73 m2=mildly to moderately decreased (G3a); eGFR 30–44 mL/min/1.73 m2= moderately to severely decreased (G3b); eGFR 15–29 mL/min/1.73 m2=severely decreased (G4); eGFR <15 mL/min/1.73 m2=kidney failure (G5).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013;3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
Patients like Kathy who have high albuminuria and low eGFR face ~5x greater risk of CV death than patients with T2D alone5,6†
Risk of CV mortality based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013;3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
† Based on the 2005 double-blind placebo-controlled FIELD trial of 200 mg once-daily micronized fenofibrate or placebo in 9795 patients with T2D and mild dyslipidemia. Patients with macroalbuminuria and eGFR 30 to 59 mL/min/1.73 m2 had ~5x greater risk of CV death than patients with no albuminuria and eGFR ≥90 mL/min/1.73 m2.6
Risk of CV mortality based on eGFR and albuminuria categories (green=low to no risk; yellow=moderately increased risk; orange=high risk; red=very high risk).
Adapted with permission from KDIGO. Levey AS, de Jong PE, Coresh J, et al. Chapter 2: Definition, identification, and prediction of CKD progression. Kidney Int Suppl. 2013;3(1):63-72. Accessed: https://www.kisupplements.org/article/S2157-1716(15)31102-3/fulltext
† Based on the 2005 double-blind placebo-controlled FIELD trial of 200 mg once-daily micronized fenofibrate or placebo in 9795 patients with T2D and mild dyslipidemia. Patients with macroalbuminuria and eGFR 30 to 59 mL/min/1.73 m2 had ~5x greater risk of CV death than patients with no albuminuria and eGFR ≥90 mL/min/1.73 m2.6
ACEi=angiotensin-converting enzyme inhibitor; ACR=albumin-to-creatinine ratio; ARB=angiotensin receptor blocker; BP=blood pressure; CKD=chronic kidney disease; CV=cardiovascular; eGFR=estimated glomerular filtration rate; GLP-1=glucagon-like peptide-1; HbA1c=glycated hemoglobin; KDIGO=Kidney Disease: Improving Global Outcomes; MI=myocardial infarction; MOA=mechanism of action; MOD=mechanism of disease; SGLT2=sodium-glucose cotransporter 2; T2D=type 2 diabetes; UACR=urine albumin-to-creatinine ratio.
INDICATION:
KERENDIA is indicated to reduce the
risk of sustained eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D)
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS:
- Concomitant use with strong CYP3A4 inhibitors
- Patients with adrenal insufficiency
WARNINGS AND PRECAUTIONS:
- Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5.0 mEq/L
Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium
MOST COMMON ADVERSE REACTIONS:
- From the pooled data of 2 placebo-controlled studies, the adverse reactions reported in ≥1% of patients on KERENDIA and more frequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs 3.9%), and hyponatremia (1.3% vs 0.7%)
DRUG INTERACTIONS:
- Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4 inhibitors is contraindicated. Avoid concomitant intake of grapefruit or grapefruit juice
- Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug initiation or dosage adjustment of either KERENDIA or the moderate or weak CYP3A4 inhibitor and adjust KERENDIA dosage as appropriate
- Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with strong or moderate CYP3A4 inducers
USE IN SPECIFIC POPULATIONS:
- Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day after treatment
- Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic impairment (Child Pugh C) and consider additional serum potassium monitoring with moderate hepatic impairment (Child Pugh B)
Please read the Prescribing Information for KERENDIA.
References: 1. Afkarian M, et al. J Am Soc Nephrol. 2013;24(2):302-308. doi:10.1681/ASN.2012070718. 2. Bailey RA, et al. BMC Res Notes. 2014;7:415. doi:10.1186/1756-0500-7-415. 3. Kidney Disease: Improving Global Outcomes (KDIGO) Diabetes Work Group. Kidney Int. 2020;98(4S):S1-S115. doi:10.1016/j.kint.2020.06.019. 4. KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals, Inc.; September 2022. 5. Kidney Disease: Improving Global Outcomes (KDIGO) CKD Work Group. Kidney Intl Suppl. 2013;3(1):1-150. doi:10.1038/kisup.2012.73. 6. Drury PL, et al. Diabetologia. 2011;54(1):32-43. doi:10.1007/s00125-010-1854-1.
