NCT00340678

Renoprotection in Early Diabetic Nephropathy in Pima Indians

170 people

72.9%

27.1%

124 womenmiddle line = equal numbers46 men

Phase: PHASE3
Paid for by: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Finished: 2014-03
Health conditions: Diabetic Nephropathy
Who could join: Anyone
Ages: 18 Years – 65 Years
Average age: mean 41.3 years
Age 65+: Not reported
Weight (BMI): mean 35.7 kg/(m^2)
Pregnancy recorded: Not reported
Menopause recorded: Not reported
Results shown by sex: Not split by sex
Race: Not reported

No pregnant women
Women who were pregnant could not join.
“Pregnancy. Women of childbearing potential must have a negative pregnancy test prior to entry and every three months during the study.”
No women who could get pregnant
Most women roughly 15–50 years old were turned away.
“Pregnancy. Women of childbearing potential must have a negative pregnancy test prior to entry and every three months during the study.”
Weight limit (BMI)
Women with a higher (or lower) body weight were turned away.
“Massive obesity with body mass index greater than or equal to 45 kg/m(2).”
No kidney or liver problems
Women with kidney or liver problems were turned away.
“Non-diabetic renal disease.”
No heart disease
Women with heart disease, heart rhythm problems or a past heart attack were turned away.
“Clinically significant disorders of the liver, cardiovascular disease, cerebrovascular disease, peripheral vascular disease, pulmonary diseases, renal-urinary disorders, gastrointestinal disorders, or hematocrit levels less than or equal to…”
No cancer
Women with current or past cancer were turned away.
“Renovascular or malignant hypertension; uncontrolled hypertension despite treatment with three antihypertensive drugs; or hypertension that is being treated with antihypertensive medicines and the primary care physician or the patient refus…”

Study titles and rules are shown in their original English.