Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

Women left out

• No pregnant women

  Women who were pregnant could not join.

  “Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before patiromer administration, during the…”

• Had to use birth control

  Women who couldn't or didn't want to use birth control were turned away.

  “…lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before patiromer administration, during the study, and for one month after study completion”

• Weight limit (BMI)

  Women with a higher (or lower) body weight were turned away.

  “Body mass index (BMI) ≥ 40 kg/m2”

• No kidney or liver problems

  Women with kidney or liver problems were turned away.

  “Non-diabetic chronic kidney disease”

• No heart disease

  Women with heart disease, heart rhythm problems or a past heart attack were turned away.

  “Current diagnosis of NYHA (New York Heart Association) Class III or IV heart failure”

• No diabetes

  Women with diabetes were turned away.

  “Type 1 diabetes mellitus”

• No cancer

  Women with current or past cancer were turned away.

  “Active cancer, currently on cancer treatment or history of cancer in the past 2 years except for non-melanocytic skin cancer which is considered cured”

Study titles and rules are shown in their original English.