Phase 3 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For children (ages 5–17):

• Children between 5 and 17 years old
• Children whose kidneys are working at a reduced but not severely low level, based on a specific kidney function calculation (confirm with trial site)
• Girls who could become pregnant must have had a menstrual period in the last month
• Certain blood test results — including parathyroid hormone, alkaline phosphatase, phosphorus, and Vitamin D levels — must be within specific ranges (confirm with trial site)
• Girls who could become pregnant must be willing to use at least one reliable form of birth control for the whole study
• The child and/or their parent or guardian must be able to read and understand English or Spanish
• For children under 18, the child and/or their parent or guardian must be able to give consent to participate, as assessed by the provider

For adults (ages 18 and over):

• Adults aged 18 or older
• People whose kidneys are working at a reduced but not severely low level, based on a specific kidney function calculation (confirm with trial site)
• Women who have not yet gone through menopause must have had a menstrual period in the last month
• Certain blood test results — including parathyroid hormone, alkaline phosphatase, phosphorus, and Vitamin D levels — must be within specific ranges (confirm with trial site)
• Women who could become pregnant must be willing to use at least one reliable form of birth control for the whole study
• Must be able to read and understand English or Spanish

Who may not be able to join:

• People with high potassium levels in their blood, a history of high potassium in the last 6 months, or who are currently taking medication to lower potassium
• People who have taken alkali (bicarbonate-based) therapy in the past 12 months
• People whose resting heart tracing (ECG) shows certain abnormalities that may increase the risk of irregular heartbeat
• People whose blood bicarbonate levels are outside a specific range (confirm with trial site)
• People with low calcium levels in their blood
• People with serious other health conditions that affect the body's acid-base balance — for example, active cancer requiring chemotherapy, chronic liver failure, moderate or severe chronic lung disease, significant heart failure, sleep apnea requiring nightly breathing machine use, active kidney inflammation requiring immune-suppressing treatment, or conditions causing poor nutrient absorption such as celiac disease
• People who plan to move away from the area within the next 3 months
• People with a urine pH above a certain level, or a history of kidney stones (confirm with trial site)
• People who have had a lower limb amputation or who are unable to walk
• People with bone disease unrelated to kidney disease, such as Paget's disease or overactive parathyroid glands not caused by kidney disease
• People with untreated thyroid conditions (overactive or underactive), or Cushing's syndrome
• People with certain medical conditions that could affect how the treatment works, such as severe heart muscle damage, severe dehydration, delayed stomach emptying, pressure on the oesophagus, or a blockage or narrowing of the intestines
• People who have used certain bone or hormone medications — including bisphosphonates, denosumab, teriparatide, abaloparatide, romosozumab, raloxifene, oestrogen or testosterone therapy — or who have been on an unstable dose of steroids within the past 12 months
• People who have previously had fractures in both wrists and both shin bones
• People who have received a solid organ or liquid organ transplant
• People currently on dialysis, whose kidney function is declining rapidly, or who are expected to start dialysis or receive a transplant within 3 months
• People who are pregnant or breastfeeding
• People who are currently imprisoned or living in an institutional setting
• People who are unwilling to give informed consent to participate

Important: Always verify eligibility with the trial site directly before applying.