Preserve-Transplant Study

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

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.

Study Overview

• Status: Completed
• Conditions: Renal Insufficiency; Kidney Transplantation; Acidosis
• Intervention / Treatment: Drug: Nephrotrans; Other: Placebo

• Study Type: Interventional
• Enrollment (Actual): 240
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • BE
    • Bern, BE, Switzerland
      • Inselspital Bern, Department of Nephrology and Hypertension
  • GE
    • Geneva, GE, Switzerland
      • HUG - Néphrologie
  • ZH
    • Zurich, ZH, Switzerland
      • University Hospital Zurich, Division of Nephrology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Verum; Patients will receive Nephrotrans.	Drug: Nephrotrans; Sodium hydrogen carbonate, ATC-Code: A02AH
PLACEBO_COMPARATOR: Placebo; Patients will receive Placebo.	Other: Placebo; Identical capsules without active substance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR	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.	2 years

Collaborators and Investigators

• Sponsor: University of Zurich
• Investigators: Principal Investigator: Nilufar Mohebbi, PD Dr. med., University of Zurich; Study Director: Rudolf P Wüthrich, Prof. Dr. med., University of Zurich

Publications and helpful links

General Publications

• Wiegand A, Ritter A, Graf N, Arampatzis S, Sidler D, Hadaya K, Muller TF, Wagner CA, Wuthrich RP, Mohebbi N. Preservation of kidney function in kidney transplant recipients by alkali therapy (Preserve-Transplant Study): rationale and study protocol. BMC Nephrol. 2018 Jul 13;19(1):177. doi: 10.1186/s12882-018-0956-8.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 12, 2017
• Primary Completion (ACTUAL): June 29, 2021
• Study Completion (ACTUAL): July 26, 2021

Study Registration Dates

• First Submitted: March 31, 2017
• First Submitted That Met QC Criteria: April 5, 2017
• First Posted (ACTUAL): April 6, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Chronic kidney disease; Metabolic acidosis; Graft; Alkali; Acid base
• Additional Relevant MeSH Terms: Metabolic Diseases; Kidney Diseases; Urologic Diseases; Acid-Base Imbalance; Renal Insufficiency; Acidosis
• Other Study ID Numbers: Preserve-Transplant Study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No