AcidosisPhase 4NCT03102996
Preserve-Transplant Study
A Phase 4 study testing Nephrotrans in people with Acidosis and Renal Insufficiency, run by University of Zurich at 3 sites in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acidosis, Renal Insufficiency, Kidney Transplantation
- What is being tested?
- Nephrotrans
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 12 Jun 2017to 26 Jul 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Inselspital Bern, Department of Nephrology and Hypertension
Bern, Canton of Bern
HUG - Néphrologie
Geneva, Canton of Geneva
University Hospital Zurich, Division of Nephrology
Zurich, Canton of Zurich
About this study
Official title: 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.
- Conditions
- Acidosis, Renal Insufficiency, Kidney Transplantation
- Being tested
- Nephrotrans, Placebo
- Keywords
- Alkali, Graft, Acid base, Metabolic acidosis, Chronic kidney disease
- Medical subject headings
- Acidosis, Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NephrotransDrug
Sodium hydrogen carbonate, ATC-Code: A02AH
PlaceboOther
Identical capsules without active substance.
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | Patients will receive Nephrotrans. Receives: Drug: Nephrotrans |
| Placebo | Placebo comparator | Patients will receive Placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start12 Jun 2017
- Primary completion29 Jun 2021
- Study completion26 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AcidosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nilufar Mohebbi, PD Dr. med., Principal investigator, University of ZurichRudolf P Wüthrich, Prof. Dr. med., Study director, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102996
- Sponsor's protocol ID
- Preserve-Transplant Study
- Status last verified
- Apr 2022
- First submitted
- 31 Mar 2017
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Staub PS, Kronthaler D, Wiegand A, Dahdal S, Sidler D, Arampatzis S, Hadaya K, Seeger H, Wuthrich RP, Held U, Wagner CA, Mohebbi N, Ritter A. Effect of Sodium Bicarbonate on Indicators of Volume Retention in Metabolic Acidosis After Kidney Transplantation: A Post-Hoc Analysis. Kidney Med. 2026 Feb 11;8(4):101290. doi: 10.1016/j.xkme.2026.101290. eCollection 2026 Apr.
PubMed 41953463Mohebbi 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.
PubMed 36708734Wiegand 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.
PubMed 30001705
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preservation of Kidney Function in Kidney Transplant Recipients by Alkali Therapy (Preserve-Transplant Study): a Multi-center Randomized Single-blind Placebo- Controlled Trial
- ClinicalTrials.gov ID
- NCT03102996
- Acronym / sponsor ID
- Preserve-Transplant Study
- Conditions
- Acidosis, Renal Insufficiency, Kidney Transplantation
- Keywords
- Alkali, Graft, Acid base, Metabolic acidosis, Chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 29 Jun 2021 (actual)
- Study completion
- 26 Jul 2021 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Drug: NephrotransPatients will receive Nephrotrans. |
| Placebo | Placebo comparator | Other: PlaceboPatients will receive Placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%)
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NephrotransSodium hydrogen carbonate, ATC-Code: A02AH | Drug | Verum |
| PlaceboIdentical capsules without active substance. | Other | Placebo |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- Derived from this study: PubMed 41953463Staub PS, Kronthaler D, Wiegand A, Dahdal S, Sidler D, Arampatzis S, Hadaya K, Seeger H, Wuthrich RP, Held U, Wagner CA, Mohebbi N, Ritter A. Effect of Sodium Bicarbonate on Indicators of Volume Retention in Metabolic Acidosis After Kidney Transplantation: A Post-Hoc Analysis. Kidney Med. 2026 Feb 11;8(4):101290. doi: 10.1016/j.xkme.2026.101290. eCollection 2026 Apr.
- Derived from this study: PubMed 36708734Mohebbi 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.
- Derived from this study: PubMed 30001705Wiegand 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilufar Mohebbi, PD Dr. med. principal investigator
University of Zurich
Rudolf P Wüthrich, Prof. Dr. med. study director
University of Zurich
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nephrotrans in people with Acidosis and Renal Insufficiency, run by University of Zurich at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
eGFR (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03102996, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2022.