Kidney Week

Abstract: TH-PO764

Patiromer Treatment of Hyperkalemia in Adolescent Children with CKD: Initial Results from EMERALD

Session Information

• Pediatric CKD
  November 07, 2019 | Location: Exhibit Hall, Walter E. Washington Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Pediatric Nephrology

• 1700 Pediatric Nephrology

Authors

• Warady, Bradley A., Children's Mercy Kansas City, Kansas City, Missouri, United States

Bradley A. Warady,

• Gross, Coleman, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Coleman Gross,

• Mayo, Martha, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Martha Mayo,

• Ma, Jia, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Jia Ma,

• Yllana, Joy, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Joy Yllana,

• Shapiro, Lana, Relypsa, Inc., a Vifor Pharma Group Company, Redwood City, California, United States

Lana Shapiro,

• Schaefer, Franz S., University of Heidelberg, Heidelberg, BW, Germany

Franz S. Schaefer,

Background

Patiromer (PAT) is a sodium-free potassium (K⁺) binder approved for treatment of hyperkalemia (HK) in adults (8.4 g once daily starting dose); it is not currently approved for use in children.

Methods

EMERALD (NCT03087058), an open-label, multiple-dose study, evaluates the pharmacodynamics (PD) and safety of PAT in children (2-<18 yr) with HK and CKD. It consists of a 14-d dose finding PD phase and a 5.5-mo long-term treatment (LT) phase. Patients (pts) must have eGFR <60 mL/min/1.73m², HK (serum K [sK] 5.1-<6.5 mEq/L) and not be on hemodialysis (HD). RAASi doses must be stable for ≥28 days before screening. Up to 54 pts will be enrolled into 3 sequential cohorts based on age. Cohort specific PAT starting doses with titration to obtain a target local K level of 3.8-5.0 mEq/L are being evaluated. Up to 3 starting doses per cohort may be assessed. The primary endpoint is the change in central lab sK from baseline to Day 14. Secondary endpoints include the proportion of pts with target sK (3.8-5.0 mEq/L, central lab) at Day 14 and through Week 26.

Results

Cohort 1 (age 12 to <18 yr, now completed) pts (N=14, mean age 14.5 yr) had a mean (SD) baseline sK of 5.54 (0.32) mEq/L and eGFR of 28.7 (13.7) mL/min/1.73m². The most common etiology of CKD was CAKUT (64%) and 57% of pts were on RAASi. All pts completed the PD phase of the study; 2 pts withdrew consent in the LT phase and 1 began HD after which sK data were censored. The starting dose for all patients was 4.2 g/d; 8.4 g/d was the most common final prescribed dose at study end (33.3%). sK decreased by -0.50 (0.54) mEq/L at Day 14 (N=14) and by -1.08 (0.74) mEq/L at Week 26 (N=11); 50% and 82% of pts achieved the target sK by Day 14 and Week 26, respectively. Adverse events (AE) were observed in 71% of pts and were mostly mild or moderate in severity (one severe, none serious). The most common class of AEs was gastrointestinal disorders (43%; diarrhea [21%], flatulence [14%], nausea [14%]). There was one AE of hypokalemia. Three pts experienced AEs considered related to study drug (none severe); no AEs led to study drug discontinuation.

Conclusion

Preliminary results from EMERALD suggest a 4.2 g/d PAT starting dose with titration resulted in clinically meaningful sK reduction in adolescents with CKD and HK and was generally well tolerated.

Funding

• Commercial Support –