Preserve-Transplant Study

University of Zurich (UZH)

Status and phase

Completed

Phase 4

Conditions

Acidosis

Kidney Transplantation

Renal Insufficiency

Treatments

Drug: Nephrotrans

Other: Placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03102996

Preserve-Transplant Study

Details and patient eligibility

About

The aim of this study is to test if alkali treatment will preserve kidney graft function and diminish the progression of chronic kidney disease in renal transplant patients. Additionally the underlying mechanisms of nephrotoxicity of metabolic acidosis will be investigated in this cohort.

This study is a multi-center, prospective, randomized, single-blind (patient), placebo-controlled interventional trial to test the superiority of alkali treatment in comparison to placebo on preservation of kidney function in 300 kidney transplant recipients. The duration of the study will be 2 years for the individual participant. The patients will be randomized into 2 arms: intervention arm (sodium hydrogen carbonate, product: Nephrotrans®) and placebo arm (placebo comparator).

Several studies in CKD (chronic kidney disease) patients have shown that alkali therapy slows progression of CKD.

Enrollment

240 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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 3 months (creatinine changes ± 15%)
eGFR between 15-89 ml/min/1.73 m2
serum bicarbonate ≤ 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