HyperkalemiaPhase 3NCT05786469
Patiromer Trial in CKD Stage IIIB to V
A Phase 3 study testing Veltassa Oral Powder Product in people with Hyperkalemia, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
This phase III, prospective, randomized, double-blind, placebo-controlled trial will primarily aim to compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits, one-week… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia
- What is being tested?
- Veltassa Oral Powder Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteItaly
- Study dates
- 2 Aug 2023to 7 Nov 2024
- Phase
- Phase 3
- 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
- Provision of informed consent prior to any study-specific procedures.
- Age >18 years.
- GFR <45 ml/min/1.73m2 as per CKD-EPI equation.
- Serum potassium ≥5.0 mEq/L (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics.
- Concomitant therapy with RAAS inhibitors (ACE inhibitors, ARBs and aldosterone antagonists, such as spironolactone and finerenone).
Who cannot join
- Ongoing treatment with SPS before randomization (Patient eligibility could be reassessed during the screening period after at least one week from SPS therapy withdrawal)
- Rapidly progressive kidney disease (eGFR reduction ≥ 30% over the last three months as per CKD-Epi equation) and expected risk of progression to ESKD and need of renal replacement therapy by dialysis or transplantation within six months.
- Active systemic autoimmune diseases.
- Concomitant treatment with steroids or any other immunosuppressive agent.
- Hypersensitivity to the active ingredient or any of the excipients. Patients with Hereditary Fructose Intolerance.
- Patients with or at risk of hypercalcaemia and/or hypomagnesaemia.
Show all 17Show fewer
- Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months.
- Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications and a diuretic).
- Positive hepatitis C antibodies, hepatitis B virus surface antigens at screening.
- Known to have tested positive for human immunodeficiency virus.
- Drug or alcohol abuse.
- Female subjects who are pregnant, lactating or who intend to become pregnant before or during the study period, or within 90 days of the last dose of study treatment. Female subjects who intend to donate ova over the same time period.
- Male subjects who intend to donate sperm during the study period or for the 90 days following the last dose of study treatment.
- Male and female subjects in childbearing age not using a highly effective contraception method according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials (9)
- Inability to fully understand the potential risks and benefits related to study participation.
- Involvement in the study planning and/or conduct.
- Participation in another clinical study with an investigational product during the last month.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Centro di Ricerche Cliniche per le Malattie Rare "Aldo e Cele Daccò"
Ranica, BG, 24020
About this study
Official title: A Prospective, Double-blind, Randomized, Single Centre Trial to Evaluate the Rate of RAAS Inhibitor Withdrawal or Down-titration in Non-dialysis Patients with CKD Stage IIIb to V Randomized to Patiromer or Placebo (DROP)
This phase III, prospective, randomized, double-blind, placebo-controlled trial will primarily aim to compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits, one-week apart) in non-dialysis patients with CKD stage IIIB to V receiving best available conservative therapy, including RAAS inhibition with ACE inhibitors and/or ARBs and/or aldosterone antagonists. Patients are expected to be included during an 18-month recruitment period. All randomized patients will be maintained on active follow-up for 12 months. At 12 months, a final visit will be performed for all patients who complete the follow-up period. During this final visit, all the parameters evaluated at baseline will be reassessed and the study treatment will be discontinued. Whenever feasible, a final visit will be planned within one month also for those patients who prematurely discontinue the treatment period for any intercurrent reason (adverse event, consent withdrawal and other). After the final visit the patient will be discharged from the study and will be referred to his nephrologist with the suggestion to check serum potassium levels within three days.
Read the detailed description
Refractory hyperkalemia is among the leading causes of initiation or chronic renal replacement therapy (RRT) by extracorporeal or peritoneal dialysis in patients with chronic kidney disease (CKD). Dialysis therapy is lifesaving but has a major impact on patients' quality of life and is terribly expensive. Thus, deferring dialysis initiation by preventing hyperkalemia would have major implications for patients and health care providers.
Among patients with CKD, glomerular filtration rate (GFR) <45 ml/min/1.73 m2, older age, coexistence of diabetes or heart failure, and inhibition of the renin angiotensin aldosterone system (RAAS) by angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) or aldosterone antagonists are the major risk factors for hyperkalemia. On the other hand, RAAS inhibitors - based on randomized trial results showing the superior effect of these medications compared to other antihypertensive drug classes in slowing the progression of chronic nephropathies to end-stage renal disease (ESRD) - are first-line therapy for patients with CKD, in particular for those with proteinuric nephropathies.
However, the risk of hyperkalemia is a major impediment to adequate RAAS blockade in CKD, especially when RAAS inhibitors are used in maximal doses or are combined.
Dietary counseling, correction of metabolic acidosis and treatment with loop diuretics are key components of potassium-lowering therapy in patients with CKD. Combined therapy with potassium binders, however, is often needed to prevent or treat hyperkalemia, particularly in patients with GFR <45 ml/min/1.73 m2, concomitant diabetes and/or RAAS inhibitor therapy.
A newer potassium binder, patiromer, has been approved by FDA and EMA for the treatment of hyperkalemia. Patiromer is an organic, non-absorbed, sodium-free, potassium-binding polymer that exchanges potassium for calcium in the gastrointestinal tract. Because of the remarkably good risk/benefit profile, it is conceivable that patiromer may safely improve hyperkalemia control and reduce the need of RAAS inhibition interruption or down-titration (not only of ACE inhibitors and ARBs but also of potassium sparing diuretics such as spironolactone, eplerenone and finerenone) in patients with severe CKD. In turn, this could translate into improved nephroprotection and deferred initiation of dialysis, particularly in non-dialysis patients with CKD stage IV to V. This hypothesis, however, must be tested in prospective randomized controlled trials.
- Conditions
- Hyperkalemia
- Being tested
- Veltassa Oral Powder Product, Placebo
- Keywords
- Chronic Kidney Diseases, Hyperkalemia, Potassium Binders
- Medical subject headings
- Hyperkalemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veltassa Oral Powder ProductDrug
The recommended starting dose is 8.4 g of patiromer, once daily (equivalent to one packet of the active ingredient, once daily). The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued.
Patients are expected to be included during an 18-month recruitment period. The last randomized patient will be maintained on active follow-up for 6 months. All other randomized patients will be maintained on active follow-up until the last randomized patient will have completed the planned 6-month follow-up period. Thus, the follow-up period will be expected to range from a minimum of 6 months for the last randomized patient to a maximum of 24 months for the first randomized patient
PlaceboOther
The recommended starting dose is 8.4 g of patiromer, once daily (equivalent to one packet of the active ingredient, once daily). The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued.
Patients are expected to be included during an 18-month recruitment period. The last randomized patient will be maintained on active follow-up for 6 months. All other randomized patients will be maintained on active follow-up until the last randomized patient will have completed the planned 6-month follow-up period. Thus, the follow-up period will be expected to range from a minimum of 6 months for the last randomized patient to a maximum of 24 months for the first randomized patient
| Study group | Role | What they receive |
|---|---|---|
| Participants randomized to receive one 8.4 g packet of patiromer per day | Experimental | Patiromer is an organic, non-absorbed, sodium-free, potassium-binding polymer that exchanges potassium for calcium in the gastrointestinal tract. Receives: Drug: Veltassa Oral Powder Product |
| Participants randomized to receive one identical packet containing placebo | Placebo comparator | Active study treatment and placebo will be provided by Vifor Pharma and will be indistinguishable from one another in terms of labelling and instructions Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia
Number of patients who withdraw or reduce RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits one-week apart)
Measured: 6 months
Secondary outcomes (8)
To compare changes in serum potassium normalization between the two treatment groups
Changes in Serum potassium normalization (serum K+<5.0 mEq/l considered as a dichotomous end point) for at least two consecutive visits one week apart
Measured: 6 months
To compare changes in metabolic laboratory parameters between the two treatment groups
Changes in: serum potassium mEq/l levels considered as a continuous variable; serum calcium (mg/dl) levels; serum phosphate (mg/dl) levels; serum Magnesium (mEq/l) levels; serum intact parathyroid hormone (mg/dl) levels; serum 1,25-dihydroxyvitamin D (mg/dl) levels; 24-hour urinary calcium (mg/24h) excretion; 24-hour urinary phosphate (mg/24h) excretion; 24-hour urinary magnesium (mg/24h) excretion; Plasma renin (μU/ml) activity; serum aldosterone (ng/dl) levels; 24-hour urinary aldosterone (μg/24h) excretion; blood pH (-) levels; blood Base Excess (mmol/l) level
Measured: 6 months
To compare changes in renal function parameters between the two treatment groups
Changes in measured GFR (mL/min) values with iohexol plasma clearance technique; 24-hour albuminuria (μg/min) excretion; 24-hour proteinuria (g/24h) excretion; 24-hour urinary albumin/creatinine (A/C) (mg/g) ratio; 24-hour urinary protein/creatinine (P/C) (mg/g) ratio; Urinary spot morning albumin/creatinine (A/C) (mg/g) ratio; Urinary spot morning protein/creatinine (P/C) (mg/g) ratio
Measured: 6 months
To compare change in clinical parameters between the two treatment groups
Number of participants requiring renal replacement therapy because of ESRD; number of participants requiring SPS therapy
Measured: 6 months
To compare events between the two treatment groups
Number of Fatal and non-fatal cardiovascular events; number of serious, non-serious and treatment-related adverse events
Measured: 6 months
To compare costs between the two treatment groups
Treatment costs for the study drugs, dialysis therapy and treatment-related complications
Measured: 6 months
To compare questionnaire replies between the two treatment groups
Quality of life as assessed using the Italian versions of validated questionnaires such as the SF-12 questionnaire.
All items in the questionnaire apply the same response method, but with a variable and weighted score for each item.
Measured: 6 months
To compare safety between the two study groups
Number of participant that develop hypokalemia (K+<3.5 mEq/L); Number of participant that develop hypomagnesemia (Mg++ <1.41 mg/dL); Number of participant that withdraw study treatment because of side effects
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2023
- Study start2 Aug 2023
- Primary completion7 Nov 2024
- Study completion7 Nov 2024
Why it stopped: Unable to reach planned study sample size due to increased patient failure to meet inclusion criteria.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperkalemiaStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- DOUBLE-BLIND, RANDOMIZED, SINGLE CENTRE TRIAL
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Vifor Pharma
- Responsible party
- Sponsor
- Investigators
- Giuseppe Remuzzi, MD, Study director, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05786469
- Sponsor's protocol ID
- DROP
- Other IDs
- 2023-503984-41-00, 2023
- Status last verified
- Nov 2024
- First submitted
- 1 Mar 2023
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Single Centre Trial to Evaluate the Rate of RAAS Inhibitor Withdrawal or Down-titration in Non-dialysis Patients with CKD Stage IIIb to V Randomized to Patiromer or Placebo (DROP)
- ClinicalTrials.gov ID
- NCT05786469
- Acronym / sponsor ID
- DROP
- Conditions
- Hyperkalemia
- Keywords
- Chronic Kidney Diseases, Hyperkalemia, Potassium Binders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach planned study sample size due to increased patient failure to meet inclusion criteria.
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Vifor Pharma
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 7 Nov 2024 (actual)
- Study completion
- 7 Nov 2024 (actual)
- First posted
- 27 Mar 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.
This phase III, prospective, randomized, double-blind, placebo-controlled trial will primarily aim to compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits, one-week apart) in non-dialysis patients with CKD stage IIIB to V receiving best available conservative therapy, including RAAS inhibition with ACE inhibitors and/or ARBs and/or aldosterone antagonists. Patients are expected to be included during an 18-month recruitment period. All randomized patients will be maintained on active follow-up for 12 months. At 12 months, a final visit will be performed for all patients who complete the follow-up period. During this final visit, all the parameters evaluated at baseline will be reassessed and the study treatment will be discontinued. Whenever feasible, a final visit will be planned within one month also for those patients who prematurely discontinue the treatment period for any intercurrent reason (adverse event, consent withdrawal and other). After the final visit the patient will be discharged from the study and will be referred to his nephrologist with the suggestion to check serum potassium levels within three days.
Detailed description
Refractory hyperkalemia is among the leading causes of initiation or chronic renal replacement therapy (RRT) by extracorporeal or peritoneal dialysis in patients with chronic kidney disease (CKD). Dialysis therapy is lifesaving but has a major impact on patients' quality of life and is terribly expensive. Thus, deferring dialysis initiation by preventing hyperkalemia would have major implications for patients and health care providers.
Among patients with CKD, glomerular filtration rate (GFR) <45 ml/min/1.73 m2, older age, coexistence of diabetes or heart failure, and inhibition of the renin angiotensin aldosterone system (RAAS) by angiotensin-converting-enzyme (ACE) inhibitors, angiotensin receptor blockers (ARBs) or aldosterone antagonists are the major risk factors for hyperkalemia. On the other hand, RAAS inhibitors - based on randomized trial results showing the superior effect of these medications compared to other antihypertensive drug classes in slowing the progression of chronic nephropathies to end-stage renal disease (ESRD) - are first-line therapy for patients with CKD, in particular for those with proteinuric nephropathies.
However, the risk of hyperkalemia is a major impediment to adequate RAAS blockade in CKD, especially when RAAS inhibitors are used in maximal doses or are combined.
Dietary counseling, correction of metabolic acidosis and treatment with loop diuretics are key components of potassium-lowering therapy in patients with CKD. Combined therapy with potassium binders, however, is often needed to prevent or treat hyperkalemia, particularly in patients with GFR <45 ml/min/1.73 m2, concomitant diabetes and/or RAAS inhibitor therapy.
A newer potassium binder, patiromer, has been approved by FDA and EMA for the treatment of hyperkalemia. Patiromer is an organic, non-absorbed, sodium-free, potassium-binding polymer that exchanges potassium for calcium in the gastrointestinal tract. Because of the remarkably good risk/benefit profile, it is conceivable that patiromer may safely improve hyperkalemia control and reduce the need of RAAS inhibition interruption or down-titration (not only of ACE inhibitors and ARBs but also of potassium sparing diuretics such as spironolactone, eplerenone and finerenone) in patients with severe CKD. In turn, this could translate into improved nephroprotection and deferred initiation of dialysis, particularly in non-dialysis patients with CKD stage IV to V. This hypothesis, however, must be tested in prospective randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- DOUBLE-BLIND, RANDOMIZED, SINGLE CENTRE TRIAL
| Arm | Type | Receives |
|---|---|---|
| Participants randomized to receive one 8.4 g packet of patiromer per day | Experimental | Drug: Veltassa Oral Powder ProductPatiromer is an organic, non-absorbed, sodium-free, potassium-binding polymer that exchanges potassium for calcium in the gastrointestinal tract. |
| Participants randomized to receive one identical packet containing placebo | Placebo comparator | Other: PlaceboActive study treatment and placebo will be provided by Vifor Pharma and will be indistinguishable from one another in terms of labelling and instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provision of informed consent prior to any study-specific procedures.
- Age >18 years.
- GFR <45 ml/min/1.73m2 as per CKD-EPI equation.
- Serum potassium ≥5.0 mEq/L (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics.
- Concomitant therapy with RAAS inhibitors (ACE inhibitors, ARBs and aldosterone antagonists, such as spironolactone and finerenone).
Key exclusion criteria (17 listed)
- Ongoing treatment with SPS before randomization (Patient eligibility could be reassessed during the screening period after at least one week from SPS therapy withdrawal)
- Rapidly progressive kidney disease (eGFR reduction ≥ 30% over the last three months as per CKD-Epi equation) and expected risk of progression to ESKD and need of renal replacement therapy by dialysis or transplantation within six months.
- Active systemic autoimmune diseases.
- Concomitant treatment with steroids or any other immunosuppressive agent.
- Hypersensitivity to the active ingredient or any of the excipients. Patients with Hereditary Fructose Intolerance.
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 |
|---|---|---|
| Veltassa Oral Powder ProductThe recommended starting dose is 8.4 g of patiromer, once daily (equivalent to one packet of the active ingredient, once daily). The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued. Patients are expected to be included during an 18-month recruitment period. The last randomized patient will be maintained on active follow-up for 6 months. All other randomized patients will be maintained on active follow-up until the last randomized patient will have completed the planned 6-month follow-up period. Thus, the follow-up period will be expected to range from a minimum of 6 months for the last randomized patient to a maximum of 24 months for the first randomized patient | Drug | Participants randomized to receive one 8.4 g packet of patiromer per day |
| PlaceboThe recommended starting dose is 8.4 g of patiromer, once daily (equivalent to one packet of the active ingredient, once daily). The daily dose may be adjusted in intervals of one week or longer, based on the serum potassium level and the desired target range. The daily dose may be increased or decreased by 8.4 g as necessary to reach the desired target range, up to a maximum dose of 25.2 g daily. If serum potassium falls below the desired range, the dose should be reduced or discontinued. Patients are expected to be included during an 18-month recruitment period. The last randomized patient will be maintained on active follow-up for 6 months. All other randomized patients will be maintained on active follow-up until the last randomized patient will have completed the planned 6-month follow-up period. Thus, the follow-up period will be expected to range from a minimum of 6 months for the last randomized patient to a maximum of 24 months for the first randomized patient | Other | Participants randomized to receive one identical packet containing placebo |
Primary outcome
To compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia
Time frame: 6 months
Number of patients who withdraw or reduce RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits one-week apart)
8 secondary outcomes
To compare changes in serum potassium normalization between the two treatment groups
Time frame: 6 months
To compare changes in metabolic laboratory parameters between the two treatment groups
Time frame: 6 months
To compare changes in renal function parameters between the two treatment groups
Time frame: 6 months
To compare change in clinical parameters between the two treatment groups
Time frame: 6 months
To compare events between the two treatment groups
Time frame: 6 months
To compare costs between the two treatment groups
Time frame: 6 months
To compare questionnaire replies between the two treatment groups
Time frame: 6 months
To compare safety between the two study groups
Time frame: 6 months
Results and safety
The study was stopped early (reason given: Unable to reach planned study sample size due to increased patient failure to meet inclusion criteria.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- 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.
Giuseppe Remuzzi, MD study director
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Veltassa Oral Powder Product in people with Hyperkalemia, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 5 inclusion and 17 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: stopped early, as of the sponsor's last update on 12 Nov 2024. 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 Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: Unable to reach planned study sample size due to increased patient failure to meet inclusion criteria.). Results are not available in the source record.
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?
To compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (time frame: 6 months). 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 12 Nov 2024.