NCT01885559
HALT Progression of Polycystic Kidney Disease Study B
See it on ClinicalTrials.gov ↗486 people
51.6%
48.4%
251 womenmiddle line = equal numbers235 men
- Phase
- PHASE3
- Paid for by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Finished
- 2014-06
- Health conditions
- Kidney, Polycystic
- Who could join
- Anyone
- Ages
- 15 Years – 64 Years
- Average age
- mean 48.7 years
- Age 65+
- Not reported
- Weight (BMI)
- mean 28.0 kg/m2
- Pregnancy recorded
- Not reported
- Menopause recorded
- Not reported
- Results shown by sex
- Not split by sex
- Race
- White 93.4% · Black / African American 2.5% · More than one race 1.6% · Asian 1.4% · American Indian / Alaska Native 0.8% · Not reported 0.2% · Native Hawaiian / Pacific Islander 0%
Women left out
- Age limit under 65
Older women were turned away, even though they often take this medicine.
“Maximum age: 64 Years.”
- No pregnant women
Women who were pregnant could not join.
“Pregnant/intention to become pregnant in 4-6 yrs.”
- No kidney or liver problems
Women with kidney or liver problems were turned away.
“Spot urine albumin-to-creatinine ratio of \>0.5 (Study A) or ≥1.0 (Study B) and/or findings suggestive of kidney disease other than ADPKD.”
- No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“…other than hypertension) for β-blocker or calcium channel blocker therapy (e.g. angina, past myocardial infarction, arrhythmia), unless approved by the site principal investigator. (PI may choose to accept an individual who is on only a sma…”
- No diabetes
Women with diabetes were turned away.
“Diabetes requiring insulin or oral hypoglycemic agents / fasting serum glucose of \>126 mg/dl / random non-fasting glucose of \>200 mg/dl.”
Study titles and rules are shown in their original English.