Autosomal Dominant Polycystic Kidney DiseasePhase 2NCT05870007

Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease

A Phase 2 study testing Atorvastatin 20 Mg Oral Tablet and Sodium Bicarbonate 600 Mg Oral Tablet in people with Autosomal Dominant Polycystic Kidney Disease and Chronic Kidney Diseases, run by Taipei Medical University Shuang Ho Hospital at 3 sites in Taiwan.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Autosomal Dominant Polycystic Kidney Disease, Chronic Kidney Diseases
What is being tested?: Atorvastatin 20 Mg Oral Tablet and Sodium Bicarbonate 600 Mg Oral Tablet
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 3 sitesTaiwan
Study dates: May 2023to Dec 2026
Phase: Phase 2
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

Patient voluntarily gives informed consent to participate in the study and signed study's IC and HIPAA.
Patient is age 18 or older at the time of consent.
If applicable, female of reproductive potential (Females who are successfully sterilized (surgical sterilization methods include hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential) must be non-pregnant (as confirmed by a urine pregnancy test at screening) and non-lactating, and agree:
Either abstain from intercourse (when it is in line with their preferred and usual lifestyle), or
Use 2 medically acceptable, highly-effective forms of contraception for the duration of study, and at least 30 days after discontinuing study drug (highly-effective forms of contraception can include approved hormonal contraceptives (oral, injectable, and implantable), and barrier methods (such as a condom or diaphragm) when used with a spermicide.))
Patients has ADPKD diagnosed by unified criteria using a combination of ultrasound results, genotyping and MRI as needed (1, 2). Kidney ultrasound is usually used for screening because it is safe, effective, and inexpensive. Diagnostic criteria are based upon whether the genotype is known. Disease severity varies between the different genotypes. The great majority of patients at risk for ADPKD are from families with an unknown genotype. This diagnosis will take place prior to recruitment / inclusion into the study.

Show all 14Show fewer

The following ultrasonographic criteria for the diagnosis of ADPKD are for at-risk patients from families of where the genotype is not known:
If the patient is between 18 and 39 years of age, at least three unilateral or bilateral kidney cysts. The specificity and positive predictive value at this age-range is 100 percent. (sensitivity of 82 and 96 percent for individuals between 15 and 29 years and between 30 to 39 years of age, respectively).
If the patient is 40 to 59 years of age, at least two cysts in each kidney (sensitivity, specificity, and positive predictive value of 90, 100, and 100 percent, respectively).
Among individuals 60 years or older, at least four cysts in each kidney. (100 percent sensitivity and specificity).
The above patients with estimated GFR ≥30 ml/min i.e. with stage 1-3b CKD
Plasma bicarbonate ≤ 25 mMol/L
Metabolic acidosis
The patient agrees to immediately inform Investigator and research coordinator of any changes or planned changes in concomitant medication

Who cannot join

Patients with known allergy or sensitive to Atorvastatin or NaHCO3
Acute coronary disease, liver disease, muscle disease, or a history of pulmonary edema
Creatine Phospho Kinase (CPK) > 2ULN (2.5 ULN in African Americans). Elevated creatine phosphokinase could be a marker of rhabdomyolysis, which is a potential side effect of pravastatin. In general, patients with African American ancestry can have higher normal level of CPK
Patients with systemic disease that impacting kidney per Investigator's decision
Patients with known unstable cerebral aneurysm per Investigator's decision
Pregnancy or lactation, or patients who refuse to use recommended contraception methods

Show all 15Show fewer

Proteinuria > 1000 mg/day
History of non-compliance of medication per Investigator's decision
Patients with uncontrolled hypertension, edema, or development of severe MA as per Investigator's decision
History of cancer
History of liver disease: hepatic failure/shock, cirrhosis
Current or planned use of any of prohibited concomitant medication
Patients with history of nephrolithiasis
Following medications prohibited at the time of enrollment and during the study and if the patient is started on these medications then the patient will be excluded from the study:
rapamycin or its analogues tolvaptan spironolactone cimetidine and ketoconazole erythromycin cyclosporine gemfibrozil colchicine niacin (>1 g/day) other lipid lowering medications in the class of statins

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Taiwan3 sites

Shuang Ho Hospital
New Taipei City, 235
Taipei Medical University Hospital
Taipei
Wan Fang Hospital
Taipei

Other trials in Taiwan

About this study

Official title: Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease, A Pilot Trial for Safety and Feasibility

Polycystic Kidney Disease (PKD) is the most common genetic disease leading to End Stage Kidney Disease (ESKD), affecting between 1 in 500-1000 individuals from every ethnic group. The autosomal dominant (ADPKD) form arises from a two-hit downregulation of proteins encoded by either PKD1 or PKD2. Although many potential therapies have been studied to slow progression of ADPKD, none to date have been proven to be both safe and effective in slowing disease progression. Cholesterol-lowering agents called statins have shown promise in the treatment of younger ADPKD patients, reducing inflammation and progression as assessed by kidney growth, but their utility appears to be limited in older populations and those with more advanced chronic kidney disease (CKD). Recent evidence suggests that acidosis, as often seen in patients with worsening CKD and which may enhance CKD progression, limits the effectiveness of statins and enhances their potential toxicity. The investigators thus hypothesize that correction of acidosis along with statin treatment will be a safe and effective therapeutic regimen to slow CKD progression in the adult ADPKD population and improve overall quality of life in these patients. To test this hypothesis, the investigators will conduct a pilot open-label randomized clinical trial in ADPKD patients with estimated GFR >45 min (Stage 1-3a CKD) comparing three treatment groups: control, atorvastatin (20 mg po qd), and atorvastatin plus sodium bicarbonate tablets (upto 1800mg po total daily dose) over one year. At the beginning of the study, the investigators will determine the genotype of the trial participants. During the study period, through study visits along with serial blood draws and urinary measurements, the investigators will evaluate safety and tolerability of these treatment regimens, follow renal function and investigate the role of these treatments on acidosis, inflammatory and metabolic biomarkers in patients enrolled at an outpatient facility. Serial follow-up imaging study will also be done in selected patients. This study will establish the framework for larger clinical trials in ADPKD. Moreover, if the results of this study suggest safety/tolerability or potential benefits of statins and alkali therapy in this ADPKD population, the investigators will seek extramural funding for a larger clinical trial to test this therapeutic strategy in ADPKD.

Conditions: Autosomal Dominant Polycystic Kidney Disease, Chronic Kidney Diseases
Being tested: Atorvastatin 20 Mg Oral Tablet, Sodium Bicarbonate 600 Mg Oral Tablet
Medical subject headings: Polycystic Kidney, Autosomal Dominant, Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atorvastatin 20 Mg Oral TabletDrug
Atorvastatin 20mg
Sodium Bicarbonate 600 Mg Oral TabletDrug
Sodium bicarbonate would be titrated up to 1800mg per day according to metabolic acidosis severity during clinical follow-up

Study groups in NCT05870007
Study group	Role	What they receive
Control group	No intervention	Standard treatment alone
Atorvastatin	Active comparator	Standard treatment + Atorvastatin 20mg QD Receives: Drug: Atorvastatin 20 Mg Oral Tablet
Atorvastatin AND Alkali	Active comparator	Standard treatment + Atorvastatin 20mg QD + Sodium Bicarbonate therapy up to 1800mg per day Receives: Drug: Atorvastatin 20 Mg Oral Tablet; Drug: Sodium Bicarbonate 600 Mg Oral Tablet

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in kidney function in patients enrolled in different arms of the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum creatinine-derived estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation, to evaluate kidney function.
Measured: 12 months
Changes in kidney function in patients enrolled in different arms of the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum blood urea nitrogen (BUN), to evaluate kidney function.
Measured: 12 months
Changes in kidney function in patients enrolled in different arms of the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum sodium level (Na), to evaluate kidney function.
Measured: 12 months
Changes in kidney function in patients enrolled in different arms of the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum potassium level (K), to evaluate kidney function.
Measured: 12 months
Changes in liver function in patients enrolled in different arms of the study
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with ALT will be evaluated at the end of the trial.
Measured: 12 months
Changes in liver function in patients enrolled in different arms of the study
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with AST will be evaluated at the end of the trial.
Measured: 12 months
Changes in liver function in patients enrolled in different arms of the study
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with total bilirubin will be evaluated at the end of the trial.
Measured: 12 months
Changes in liver function in patients enrolled in different arms of the study
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with increase in prothrombin time will be evaluated at the end of the trial.
Measured: 12 months
Changes in muscle injury marker function in patients enrolled in different arms of the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on creatine phospho kinase (CPK) in patients with ADPKD compared to Atorvastatin alone or Standard therapy.
Measured: 12 months
Changes in muscle tenderness in patients enrolled in the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on muscle tenderness in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The physical exam will evaluate tenderness to palpation in major muscle groups such as leg, arm and back muscles. It will be graded as presence or absence. The patients will only be enrolled if there is absence of tenderness in muscles upon palpation on physical exam. If there is tenderness on exam or the patient reports tenderness that is then confirmed by exam the patient will be removed from the study.
Measured: 12 months
Changes in blood pressure in patients enrolled in different arms of the study
The investigators will estimate the effect of Atorvastatin and NaHCO3 on blood pressure (systolic and diastolic) in patients with ADPKD compared to Atorvastatin alone or Standard therapy
Measured: 12 months

Secondary outcomes (3)

Urinary alkalinization changes
These parameters will be ascertained by measurements of urinary pH.
Measured: 12 months
Inflammatory markers in blood and urine
The investigators will assess inflammatory markers (interleukins, prostaglandins and other cytokines) in leukocytes, plasma, and urine in the different study groups.
The biomarkers that will be measured are
HETE / HODE species phospho-AMPK Inflammatory and metabolic biomarkers: NGAL, KIM1 in blood and urine.
Measured: 12 months
AMPK pathway activation
The investigators will determine whether and to what extent the AMPK pathway is activated in leukocytes and urine derived from patients in the study groups at the different study visits. Concentration of AMPK pathway-related metabolites in serum and urine would be measured (Creatinine, Osmolality, Lactate, Pyruvate, Succinate, Total Protein, PKM2, LDHA, PDK1).
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2023Dec 2026

First posted23 May 2023
Study startMay 2023 (estimated)
Primary completionDec 2025 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Autosomal Dominant Polycystic Kidney DiseaseStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05870007
Sponsor's protocol ID: TMU-JIRB N202208049
Status last verified: Jan 2023
First submitted: 12 Apr 2023
Last updated: 23 May 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
PubMed 39356039

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
ADPKD (Autosomal Dominant Polycystic Kidney Disease), Renal Edema
RecruitingPhase 1
Absorption, Distribution, Metabolism, and Excretion of 14C-VX-407 After a Single Oral Dose
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders

All Autosomal Dominant Polycystic Kidney Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Atorvastatin and Alkali Therapy in Patients With Autosomal Dominant Polycystic Kidney Disease, A Pilot Trial for Safety and Feasibility
ClinicalTrials.gov ID: NCT05870007
Acronym / sponsor ID: TMU-JIRB N202208049
Conditions: Autosomal Dominant Polycystic Kidney Disease, Chronic Kidney Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Enrolling by invitation
Enrolment: 30 participants (estimated)
Lead sponsor: Taipei Medical University Shuang Ho HospitalUniversity, hospital or other
Collaborators: University of Southern California
Study start: May 2023 (estimated)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 23 May 2023 (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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Control group	No intervention	–Standard treatment alone
Atorvastatin	Active comparator	Drug: Atorvastatin 20 Mg Oral TabletStandard treatment + Atorvastatin 20mg QD
Atorvastatin AND Alkali	Active comparator	Drug: Atorvastatin 20 Mg Oral Tablet, Drug: Sodium Bicarbonate 600 Mg Oral TabletStandard treatment + Atorvastatin 20mg QD + Sodium Bicarbonate therapy up to 1800mg per day

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (14 listed)

Patient voluntarily gives informed consent to participate in the study and signed study's IC and HIPAA.
Patient is age 18 or older at the time of consent.
If applicable, female of reproductive potential (Females who are successfully sterilized (surgical sterilization methods include hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or are postmenopausal (defined as amenorrhea for at least 12 consecutive months) are not considered to be of reproductive potential) must be non-pregnant (as confirmed by a urine pregnancy test at screening) and non-lactating, and agree:
Patients has ADPKD diagnosed by unified criteria using a combination of ultrasound results, genotyping and MRI as needed (1, 2). Kidney ultrasound is usually used for screening because it is safe, effective, and inexpensive. Diagnostic criteria are based upon whether the genotype is known. Disease severity varies between the different genotypes. The great majority of patients at risk for ADPKD are from families with an unknown genotype. This diagnosis will take place prior to recruitment / inclusion into the study.
The following ultrasonographic criteria for the diagnosis of ADPKD are for at-risk patients from families of where the genotype is not known:

Key exclusion criteria (15 listed)

Patients with known allergy or sensitive to Atorvastatin or NaHCO3
Acute coronary disease, liver disease, muscle disease, or a history of pulmonary edema
Creatine Phospho Kinase (CPK) > 2ULN (2.5 ULN in African Americans). Elevated creatine phosphokinase could be a marker of rhabdomyolysis, which is a potential side effect of pravastatin. In general, patients with African American ancestry can have higher normal level of CPK
Patients with systemic disease that impacting kidney per Investigator's decision
Patients with known unstable cerebral aneurysm per Investigator's decision

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
Atorvastatin 20 Mg Oral TabletAtorvastatin 20mg	Drug	Atorvastatin, Atorvastatin AND Alkali
Sodium Bicarbonate 600 Mg Oral TabletSodium bicarbonate would be titrated up to 1800mg per day according to metabolic acidosis severity during clinical follow-up	Drug	Atorvastatin AND Alkali

Primary outcome

Changes in kidney function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum creatinine-derived estimated glomerular filtration rate (eGFR) calculated by CKD-EPI equation, to evaluate kidney function.
Changes in kidney function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum blood urea nitrogen (BUN), to evaluate kidney function.
Changes in kidney function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum sodium level (Na), to evaluate kidney function.
Changes in kidney function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on kidney function in patients with ADPKD compared to Atorvastatin alone or Standard therapy: serum potassium level (K), to evaluate kidney function.
Changes in liver function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with ALT will be evaluated at the end of the trial.
Changes in liver function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with AST will be evaluated at the end of the trial.
Changes in liver function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with total bilirubin will be evaluated at the end of the trial.
Changes in liver function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will test liver function test panels in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The liver function panel should be within normal limits for enrollment and continuation in the study. Liver function test with increase in prothrombin time will be evaluated at the end of the trial.
Changes in muscle injury marker function in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on creatine phospho kinase (CPK) in patients with ADPKD compared to Atorvastatin alone or Standard therapy.
Changes in muscle tenderness in patients enrolled in the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on muscle tenderness in patients with ADPKD compared to Atorvastatin alone or Standard therapy. The physical exam will evaluate tenderness to palpation in major muscle groups such as leg, arm and back muscles. It will be graded as presence or absence. The patients will only be enrolled if there is absence of tenderness in muscles upon palpation on physical exam. If there is tenderness on exam or the patient reports tenderness that is then confirmed by exam the patient will be removed from the study.
Changes in blood pressure in patients enrolled in different arms of the study
Time frame: 12 months
The investigators will estimate the effect of Atorvastatin and NaHCO3 on blood pressure (systolic and diastolic) in patients with ADPKD compared to Atorvastatin alone or Standard therapy

3 secondary outcomes

Urinary alkalinization changes
Time frame: 12 months
Inflammatory markers in blood and urine
Time frame: 12 months
AMPK pathway activation
Time frame: 12 months

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 23 May 2023.
Derived from this study: PubMed 39356039St Pierre K, Cashmore BA, Bolignano D, Zoccali C, Ruospo M, Craig JC, Strippoli GF, Mallett AJ, Green SC, Tunnicliffe DJ. Interventions for preventing the progression of autosomal dominant polycystic kidney disease. Cochrane Database Syst Rev. 2024 Oct 2;10(10):CD010294. doi: 10.1002/14651858.CD010294.pub3.
Individual participant dataSharing planned: No

Related trials for Autosomal Dominant Polycystic Kidney Disease

RecruitingObservational study
Hypertension in Children and Young People at Risk of Autosomal Dominant Polycystic Kidney Disease
Autosomal Dominant Polycystic Kidney Disease (ADPKD
Active, not recruitingObservational study
Role of ROS and cAMP-PKA Biomarkers in ADPKD
Autosomal Dominant Polycystic Kidney Disease
Not yet recruitingPhase 1
A Study to Investigate the Pharmacokinetics of JMKX003142 in Healthy Participants and Participants With Hepatic Impairment
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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.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 14 inclusion and 15 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: enrolling by invitation, as of the sponsor's last update on 23 May 2023. 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 Taiwan. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

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?

Changes in kidney function in patients enrolled in different arms of the study (time frame: 12 months). The study lists 11 primary outcomes in all. 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 NCT05870007, which also lists 1 linked publication.

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 23 May 2023.