Pyridorin (pyridoxamine dihydrochloride), part of the vitamin B6 family, is an investigational drug that preliminary data suggest may slow the progress of worsening kidney disease in people with type 2 diabetes. The purpose of this research study is to find out if Pyridorin, as compared to a placebo, can safely slow progression of kidney disease in people with type 2 diabetes and high levels of protein in the urine. A total of approximately 600 participants will be randomized in this 42 month long study with about 100 study sites globally.
- Type 2 diabetes
- Chronic kidney disease
- High blood pressure
- People who have received a solid organ transplant
- People who are receiving dialysis
- People who are allergic or had other adverse response to vitamin B6
The study starts with a screening phase that includes detailed procedures to help the study doctor decide if you meet the requirements to be in this study. After completing the screening phase, you will return to the clinic after 1 month and then about every 3 months for as long as you are in the study.
One of the study requirements is that you are on stable group of medicines to treat your kidney disease and blood pressure. If this is not met, you may need to enter an extended screening phase to allow time to adjust your blood pressure medications to keep with current guidelines for best clinical care.
Procedures to ensure safe monitoring of your health will be performed in this study at select visits. They are blood collection, urine sampling, physical examination (done by a doctor), vital signs, and an electrocardiogram (ECG). Blood collection uses 1 tablespoon of blood at each study visit. This will amount to about 15 tablespoons collected for the entire study length (42 months).