This study wants to learn how having too much acid in the blood after a kidney transplant affects your body. Researchers will look at how acid levels may impact the health of your blood vessels and your new kidney.
If you join, the study will last about 1 year (52 weeks). You’ll have 3 to 7 in-person visits and some phone check-ins. It starts with a health screening to see if you qualify. If your blood pressure is too high, you may need up to 4 weeks to adjust your medications. Once enrolled, you’ll have visits at the beginning, 6 months, and 12 months to check your blood vessels and kidney health. You’ll also give blood and urine samples, including two 24-hour urine collections. Some visits can be done by phone.
You’ll be randomly placed into one of two groups. One group will get sodium bicarbonate, a medicine approved by the FDA to treat too much acid in the blood. The other group will get a placebo, which looks the same but has no active ingredients. Neither you nor the study team will know which group you’re in. The number of pills you take depends on your weight, and you’ll take them in the morning and at night. You’ll bring back any unused pills at each visit. Your dose may change during the study, and you’ll be asked questions about your health and any side effects. You’ll have at least 3 in-person follow-up visits. You’ll be paid $100 for the first and last visits, and $50 for the 6-month visit—for a total of $250 if you complete the study.
The study will last for 52 weeks or one year.
You may be able to join if you are between 18 and 80 years old, had a kidney transplant at least one year ago, have a kidney function of 45 or higher (based on a standard test), and have blood carbon dioxide levels between 16 and 24 mEq/L.
Protocol Number: 21-3447
More information available at ClinicalTrials.gov: NCT05005793
Principal Investigator