Preserve-Transplant Study

NCT03102996 | Completed Phase 4

• 1 other identifier: Preserve-Transplant Study
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Acidosis; Renal Insufficiency; Kidney Transplantation

Keywords

Alkali; Graft; Acid base; Metabolic acidosis; Chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Verum

EXPERIMENTAL

Patients will receive Nephrotrans.

Drug: Nephrotrans

Placebo

PLACEBO COMPARATOR

Patients will receive Placebo.

Other: Placebo

Interventions

Nephrotrans DRUG

Sodium hydrogen carbonate, ATC-Code: A02AH

Verum

Placebo OTHER

Identical capsules without active substance.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (3)

Inselspital Bern, Department of Nephrology and Hypertension

Bern, Canton of Bern, Switzerland

Location

HUG - Néphrologie

Geneva, Canton of Geneva, Switzerland

Location

University Hospital Zurich, Division of Nephrology

Zurich, Canton of Zurich, Switzerland

Location

Related Publications (2)

• Mohebbi N, Ritter A, Wiegand A, Graf N, Dahdal S, Sidler D, Arampatzis S, Hadaya K, Mueller TF, Wagner CA, Wuthrich RP. Sodium bicarbonate for kidney transplant recipients with metabolic acidosis in Switzerland: a multicentre, randomised, single-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Feb 18;401(10376):557-567. doi: 10.1016/S0140-6736(22)02606-X. Epub 2023 Jan 25.

  PMID: 36708734 DERIVED

• 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.

  PMID: 30001705 DERIVED

MeSH Terms

Conditions

Acidosis; Renal Insufficiency; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nilufar Mohebbi, PD Dr. med.

  University of Zurich

  PRINCIPAL INVESTIGATOR

• Rudolf P Wüthrich, Prof. Dr. med.

  University of Zurich

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2017
• First Posted: April 6, 2017
• Study Start: June 12, 2017
• Primary Completion: June 29, 2021
• Study Completion: July 26, 2021
• Last Updated: April 22, 2022

Record last verified: 2022-04

Locations

CH (3)