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Table 2 Inclusion and Exclusion Criteria of the Preserve-Transplant Study

From: Preservation of kidney function in kidney transplant recipients by alkali therapy (Preserve-Transplant Study): rationale and study protocol

Inclusion Criteria
 • Informed consent as documented by signature
 • Age ≥ 18 years and able to give informed consent
 • ≥ 12 months after renal transplantation
 • Stable clinical condition
 • Stable graft function over the last 6 months (creatinine changes ±15%)
 • eGFR between 15 and 89 ml/min/1.73 m2
 • At least one serum bicarbonate measured ≤22 mmol/l within the last 6 months
Exclusion Criteria
 • Uncontrolled hypertension or use of > 4 antihypertensive agents
 • Uncontrolled heart failure
 • Serum potassium < 3.0 mmol/l
 • Serum sodium > 150 mmol/l
 • Use of alkali in the preceding 4 weeks
 • Use of mineralocorticoid antagonists, topiramate, carbo anhydrase inhibitors or any drugs with similar effects
 • History of noncompliance with clinic visits
 • Hereditary fructose intolerance
 • Known hypersensitivity or allergy to the drug used in this study or to peanut, sorbitol, and soy
 • Pregnancy or breastfeeding
 • Intention to become pregnant during the course of the study
 • Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases. Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
 • Suspected drug or alcohol abuse
 • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
 • Enrolment of the investigator, his/her family members, employees and other dependent persons