Chronic Kidney Disease (Stage 3-4)PASSIONNCT07444515
Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
A study testing series of questions which can change patient care in people with Chronic Kidney Disease (Stage 3-4) and Chronic Kidney Disease (Stages 4 and 5), run by Centre Hospitalier Universitaire de la Réunion at 4 sites in France.
Trial summary
We propose the following hypotheses: The use of herbal medicine is common among patients with chronic kidney disease in Réunion island. This use could influence the progression of kidney disease in these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease (Stages 4 and 5)
- What is being tested?
- series of questions which can change patient care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 4 sitesFrance
- Study dates
- 28 Jul 2026to 28 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Individual:
- Adult
- Resident of Réunion Island and planning to remain on the island for the year following enrollment
- Chronic Kidney Disease Stage 3, 4, or 5, not on dialysis
- Under the care of a nephrologist
- Able to complete a questionnaire
- Registered with social security
Who cannot join
- Individual:
- Kidney transplant recipient
- Adult under guardianship or legal protection
- Pregnant or breastfeeding women, or women planning a pregnancy during the enrollment period
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Recruiting
Groupe Hospitalier Est Réunion
Saint-Benoît
Herinirina Mamitiana RANDRIAMANANA, hm.randriamanana@gher.fr
- Recruiting
CHU Reunion site 1
Saint-Denis, 97400
Ehshaneraza ASGARALI, 0262359000, ehshaneraza.asgarali@chu-reunion.fr
- Recruiting
AURAR
Saint-Paul
Juliette BELANGER, +262 262 45 76 10, jbelanger@aurar.fr
- Recruiting
CHU Reunion site 2
Saint-Pierre
Arnaud LE FLECHER, arnaud.leflecher@chu-reunion.fr
About this study
We propose the following hypotheses:
- The use of herbal medicine is common among patients with chronic kidney disease in Réunion island.
- This use could influence the progression of kidney disease in these patients. To assess the primary inclusion criterion, patients will be easily identified by nephrologists through existing follow-up. The questionnaires will be administered after this early identification by the investigators at each center.
Read more
The primary evaluation criterion is straightforward: it aims to establish an overview of the use of herbal medicine in our patient population. This information is currently unavailable and remains crucial for measuring the extent of the issue. Our secondary criteria will involve more in-depth analysis of this use and an attempt to correlate the use of certain herbs with the rate of progression of kidney disease at one year.
We targeted patients with moderate to end-stage chronic kidney disease (KDIGO classification 3 to 5), which are the stages typically included in kidney disease studies. Furthermore, these patients are the most likely to experience a greater annual progression of their kidney disease, and the effect of herbs on this progression could be investigated. Transplant patients were not included because they are more aware of the risks of not using herbal medicine due to their use of immunosuppressants.
Read the detailed description
The use of traditional medicine is widespread globally. In Africa, the prevalence is estimated at 60%, while usage in developing countries may reach 80%. Phytotherapy is defined as the treatment or prevention of diseases using plants; it plays a role in both traditional medicine and the current "modern" market. Chronic kidney disease (CKD) is one of the most common chronic conditions worldwide, with over 800 million prevalent cases. Its prevalence is steadily rising, affecting high-income and low-to-middle-income countries alike. Patients with kidney disease may be heavily exposed to phytotherapy.
Phytotherapy has long been used to treat kidney disease, and the kidneys are a primary route for the elimination of plant-derived compounds and their metabolites. While some plants appear to possess nephroprotective properties, others may cause acute kidney injury, chronic kidney disease, kidney stones, Fanconi syndrome, or urothelial cancers. Patients with chronic kidney disease may be at particular risk of nephrotoxicity due to reduced nephron mass and polypharmacy.
Currently, there is very little data regarding the use of phytotherapy among patients with chronic kidney disease, or concerning its protective or toxic effects.
In Réunion, there is a strong culture of phytotherapy-known as *z'herbages* in Réunionese Creole. Réunion is also the French department with the highest prevalence of end-stage renal disease. Patients with chronic kidney disease in Réunion may frequently use phytotherapies-whether for renal or systemic purposes-the consequences of which remain unknown. There is therefore a clear need to map these practices in order to identify candidate plants with potential nephroprotective or nephrotoxic effects.
- Being tested
- series of questions which can change patient care
- Keywords
- phytotherapy
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
series of questions which can change patient careOther
Series of question are about self medication with plants
| Study group | Role | What they receive |
|---|---|---|
| All patient with kidney chronic disease | Experimental | Not described Receives: Other: series of questions which can change patient care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with stage 3 to 5 CKD using traditional herbal medicine at baseline
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start28 Jul 2026
- Primary completion28 Jul 2027 (estimated)
- Study completion28 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney Disease (Stage 3-4)Studies 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 N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de la Réunion
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444515
- Sponsor's protocol ID
- 2025/RUN/0033
- Acronym
- PASSION
- Status last verified
- Sep 2026
- First submitted
- 26 Feb 2026
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.
- ClinicalTrials.gov ID
- NCT07444515
- Acronym / sponsor ID
- PASSION / 2025/RUN/0033
- Keywords
- phytotherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de la RéunionUniversity, hospital or other
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 28 Jul 2027 (estimated)
- Study completion
- 28 Aug 2028 (estimated)
- First posted
- 3 Mar 2026 (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.
We propose the following hypotheses:
- The use of herbal medicine is common among patients with chronic kidney disease in Réunion island.
- This use could influence the progression of kidney disease in these patients. To assess the primary inclusion criterion, patients will be easily identified by nephrologists through existing follow-up. The questionnaires will be administered after this early identification by the investigators at each center.
The primary evaluation criterion is straightforward: it aims to establish an overview of the use of herbal medicine in our patient population. This information is currently unavailable and remains crucial for measuring the extent of the issue. Our secondary criteria will involve more in-depth analysis of this use and an attempt to correlate the use of certain herbs with the rate of progression of kidney disease at one year.
We targeted patients with moderate to end-stage chronic kidney disease (KDIGO classification 3 to 5), which are the stages typically included in kidney disease studies. Furthermore, these patients are the most likely to experience a greater annual progression of their kidney disease, and the effect of herbs on this progression could be investigated. Transplant patients were not included because they are more aware of the risks of not using herbal medicine due to their use of immunosuppressants.
Detailed description
The use of traditional medicine is widespread globally. In Africa, the prevalence is estimated at 60%, while usage in developing countries may reach 80%. Phytotherapy is defined as the treatment or prevention of diseases using plants; it plays a role in both traditional medicine and the current "modern" market. Chronic kidney disease (CKD) is one of the most common chronic conditions worldwide, with over 800 million prevalent cases. Its prevalence is steadily rising, affecting high-income and low-to-middle-income countries alike. Patients with kidney disease may be heavily exposed to phytotherapy.
Phytotherapy has long been used to treat kidney disease, and the kidneys are a primary route for the elimination of plant-derived compounds and their metabolites. While some plants appear to possess nephroprotective properties, others may cause acute kidney injury, chronic kidney disease, kidney stones, Fanconi syndrome, or urothelial cancers. Patients with chronic kidney disease may be at particular risk of nephrotoxicity due to reduced nephron mass and polypharmacy.
Currently, there is very little data regarding the use of phytotherapy among patients with chronic kidney disease, or concerning its protective or toxic effects.
In Réunion, there is a strong culture of phytotherapy-known as *z'herbages* in Réunionese Creole. Réunion is also the French department with the highest prevalence of end-stage renal disease. Patients with chronic kidney disease in Réunion may frequently use phytotherapies-whether for renal or systemic purposes-the consequences of which remain unknown. There is therefore a clear need to map these practices in order to identify candidate plants with potential nephroprotective or nephrotoxic effects.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patient with kidney chronic disease | Experimental | Other: series of questions which can change patient care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult
- Resident of Réunion Island and planning to remain on the island for the year following enrollment
- Chronic Kidney Disease Stage 3, 4, or 5, not on dialysis
- Under the care of a nephrologist
- Able to complete a questionnaire
Key exclusion criteria (4 listed)
- Kidney transplant recipient
- Adult under guardianship or legal protection
- Pregnant or breastfeeding women, or women planning a pregnancy during the enrollment period
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 |
|---|---|---|
| series of questions which can change patient careSeries of question are about self medication with plants | Other | All patient with kidney chronic disease |
Primary outcome
Proportion of patients with stage 3 to 5 CKD using traditional herbal medicine at baseline
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing series of questions which can change patient care in people with Chronic Kidney Disease (Stage 3-4) and Chronic Kidney Disease (Stages 4 and 5), run by Centre Hospitalier Universitaire de la Réunion at 4 sites in France.
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 4 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: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hospital promotion (0262359000, promotion.drci@chu-reunion.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with stage 3 to 5 CKD using traditional herbal medicine at baseline (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Sep 2026.