Chronic Kidney DiseasesPhase 1NCT04727840
Potassium Binder in CKD Patients (With Hyperkalemia) (DiPo Trial)
A Phase 1 study testing Sodium Zirconium Cyclosilicate Oral Product in people with Chronic Kidney Diseases and Hyperkalemia, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Kidney Diseases, Hyperkalemia
- What is being tested?
- Sodium Zirconium Cyclosilicate Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 15 Jan 2022
- Phase
- Phase 1
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women over the age of 18
- CKD stage 3-4 with an estimated GFR less or equal to 45 mL/min but greater than 15 mL/min
- Serum potassium level ≥5 mEq/L on two blood tests in the past 3 months but less than 6.5mEq/L
Who cannot join
- On dialysis
- Have been on SZC in the past 3 months
- Reside in a nursing home
- Pregnant patients
- Patients with known cognitive disability
- History of bowel disease such as but not limited to short bowel syndrome, bowel obstruction, inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Combined Dietary Intervention in Hyperkalemic CKD Patients With Potassium Binder (With Hyperkalemia) (DiPo Trial)
This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Additionally, we aim to assess the effects of a high potassium diet on renal function, endothelial function, acidosis, systemic inflammatory status and gut microbiota.
Read the detailed description
A diet rich in fruits and vegetables is associated with better outcomes in CKD patients. However, the presence of hyperkalemia can prevent patients from increasing plant-based foods in their diets. While hyperkalemia can have severe health consequences in advanced CKD, the decreased consumption of plant-based foods can be associated with adverse health outcomes in this population.
Sodium zirconium cyclosilicate (SZC) is a non-absorbed cation exchanger that selectively binds potassium in the intestine.
This study plans to enroll CKD patients with an eGFR ≤45mL/min and a serum potassium ≥ 5mEq/L, administering SZC to achieve normokalemia, and provide them with a diet rich in fruits and vegetables. Endothelial function, inflammatory biomarkers and stool microbiota will be measured to assess the potential benefits of providing a diet rich in fruits and vegetables, albeit rich in potassium, in advanced CKD patients. Because these patients are usually restricting the intake of plant-based proteins and foods due to the concerns of hyperkalemia, eliminating this serious and potentially-life threatening clinical condition might carry health benefits, such as improved endothelial function and decreased inflammation
- Conditions
- Chronic Kidney Diseases, Hyperkalemia
- Being tested
- Sodium Zirconium Cyclosilicate Oral Product
- Keywords
- Nutrition, Kidney Disease, Potassium binder, Sodium zirconium cyclosilicate
- Medical subject headings
- Renal Insufficiency, Chronic, Hyperkalemia, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium Zirconium Cyclosilicate Oral ProductDrug
Sodium zirconium cyclosilicate (SZC), a non-absorbed cation exchanger, selectively binds potassium in the intestine. SZC is in a powder form and will be provided to patients in packets containing 5g or 10gm of the medication. Participants will mix the contents of one packet with water (about 45mL). The drink should be stirred and drank immediately. If powder remains in the glass, then water should be added and the remainder of the drink should be consumed. Other medications should be taken 2 hours before or after SZC.
At Day 0 and Day 1, participants will be taking SZC at 10gm three times a day. A serum potassium will be checked on Day 2; if serum potassium is <5.1mEq/L, then the dose will be decreased to the maintenance dose of 5gm per day. At each serum potassium checks, the medication dosage will be adjusted accordingly.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | All 20 CKD patients will be receiving a potassium binder while consuming a tailored diet of non-potassium restricted foods Receives: Drug: Sodium Zirconium Cyclosilicate Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of Serum Potassium level
Achieve a serum potassium level less than 5mEq/L
Measured: 2 days
Secondary outcomes (4)
Change in Endothelial function
Improvement in endothelial function as measured by brachial artery ultrasound
Measured: 15 days
Change in Acidosis (serum HCO3 levels)
Changes in acidosis measured by blood parameters
Measured: 15 days
Systematic inflammatory status using serum biomarkers
Changes in inflammation measured by IL-6, CRP, Soluble urokinase-type Plasminogen Activator Receptor (suPAR), Monocyte Chemoattractant Protein-1 (MCP-1), Tumor Necrosis Factor Receptor (TNF-R), Fibroblast Growth Factor 23 (FGF23)
Measured: 15 days
Changes in gut microbiota using stool collections
We will perform 16S rRNA sequencing from stool samples to determine microbiota diversity and species determination.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2021
- Study start15 Mar 2021 (estimated)
- Primary completion15 Jan 2022 (estimated)
- Study completion15 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot study in 20 patients
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lea Borgi, Brigham and Women's Hospital
- Investigators
- Lea Borgi, MD, MMSc, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04727840
- Sponsor's protocol ID
- 2020P000975
- Status last verified
- Jan 2021
- First submitted
- 15 Jan 2021
- Last updated
- 1 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Dietary Intervention in Hyperkalemic CKD Patients With Potassium Binder (With Hyperkalemia) (DiPo Trial)
- ClinicalTrials.gov ID
- NCT04727840
- Acronym / sponsor ID
- 2020P000975
- Conditions
- Chronic Kidney Diseases, Hyperkalemia
- Keywords
- Nutrition, Kidney Disease, Potassium binder, Sodium zirconium cyclosilicate
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 15 Mar 2021 (estimated)
- Primary completion
- 15 Jan 2022 (estimated)
- Study completion
- 15 Jan 2022 (estimated)
- First posted
- 27 Jan 2021 (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.
This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Additionally, we aim to assess the effects of a high potassium diet on renal function, endothelial function, acidosis, systemic inflammatory status and gut microbiota.
Detailed description
A diet rich in fruits and vegetables is associated with better outcomes in CKD patients. However, the presence of hyperkalemia can prevent patients from increasing plant-based foods in their diets. While hyperkalemia can have severe health consequences in advanced CKD, the decreased consumption of plant-based foods can be associated with adverse health outcomes in this population.
Sodium zirconium cyclosilicate (SZC) is a non-absorbed cation exchanger that selectively binds potassium in the intestine.
This study plans to enroll CKD patients with an eGFR ≤45mL/min and a serum potassium ≥ 5mEq/L, administering SZC to achieve normokalemia, and provide them with a diet rich in fruits and vegetables. Endothelial function, inflammatory biomarkers and stool microbiota will be measured to assess the potential benefits of providing a diet rich in fruits and vegetables, albeit rich in potassium, in advanced CKD patients. Because these patients are usually restricting the intake of plant-based proteins and foods due to the concerns of hyperkalemia, eliminating this serious and potentially-life threatening clinical condition might carry health benefits, such as improved endothelial function and decreased inflammation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot study in 20 patients
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Drug: Sodium Zirconium Cyclosilicate Oral ProductAll 20 CKD patients will be receiving a potassium binder while consuming a tailored diet of non-potassium restricted foods |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women over the age of 18
- CKD stage 3-4 with an estimated GFR less or equal to 45 mL/min but greater than 15 mL/min
- Serum potassium level ≥5 mEq/L on two blood tests in the past 3 months but less than 6.5mEq/L
Key exclusion criteria (6 listed)
- On dialysis
- Have been on SZC in the past 3 months
- Reside in a nursing home
- Pregnant patients
- Patients with known cognitive disability
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 |
|---|---|---|
| Sodium Zirconium Cyclosilicate Oral ProductSodium zirconium cyclosilicate (SZC), a non-absorbed cation exchanger, selectively binds potassium in the intestine. SZC is in a powder form and will be provided to patients in packets containing 5g or 10gm of the medication. Participants will mix the contents of one packet with water (about 45mL). The drink should be stirred and drank immediately. If powder remains in the glass, then water should be added and the remainder of the drink should be consumed. Other medications should be taken 2 hours before or after SZC. At Day 0 and Day 1, participants will be taking SZC at 10gm three times a day. A serum potassium will be checked on Day 2; if serum potassium is <5.1mEq/L, then the dose will be decreased to the maintenance dose of 5gm per day. At each serum potassium checks, the medication dosage will be adjusted accordingly. | Drug | Intervention |
Primary outcome
Normalization of Serum Potassium level
Time frame: 2 days
Achieve a serum potassium level less than 5mEq/L
4 secondary outcomes
Change in Endothelial function
Time frame: 15 days
Change in Acidosis (serum HCO3 levels)
Time frame: 15 days
Systematic inflammatory status using serum biomarkers
Time frame: 15 days
Changes in gut microbiota using stool collections
Time frame: 15 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2021.
- Individual participant dataSharing planned: No
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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.
Lea Borgi, MD, MMSc principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Sodium Zirconium Cyclosilicate Oral Product in people with Chronic Kidney Diseases and Hyperkalemia, run by Brigham and Women's Hospital at 1 site in United States.
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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 1 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lea Borgi, MD, MMSc (617-264-3053, lborgi@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Normalization of Serum Potassium level (time frame: 2 days). 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 1 Feb 2021.