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NCT Number: NCT03102996

Preserve-Transplant Study

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Inselspital Bern, Department of Nephrology and Hypertension, Bern, Canton of Bern, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nephrotrans

Drug

Sodium hydrogen carbonate, ATC-Code: A02AH

Placebo

Other

Identical capsules without active substance.

Primary outcomes

  1. eGFR

    Time frame: 2 years

    Change in renal function by assessing the change in eGFR over 2 years from baseline. eGFR will be determined based on the CKD-EPI creatinine equation.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Apr 6, 2017
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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