Patiromer Trial in CKD Stage IIIB to V
Key facts
- Who runs it
- Mario Negri Institute for Pharmacological Research
- Where
- Italy1 site in 1 countryChoose a country to see its sites
- Trial code
- Status
- Terminated
- Phase
- Phase 3
- People taking part
- 2 people enrolled
- Started
- 2 Aug 2023
- Ended
- 7 Nov 2024
- Type of study
- Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
- Treatments tested
- Veltassa Oral Powder Product
- Placebo
- Record updated
- 12 November 2024
- Why it stopped
- Unable to reach planned study sample size due to increased patient failure to meet inclusion criteria.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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 take part
- Ongoing treatment with SPS before randomization (Patient eligibility could be reassessed during the screening period after at least one week from SPS therapy withdrawal)
- Concomitant treatment with steroids or any other immunosuppressive agent
- Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications and a diuretic)
- Drug or alcohol abuse
- Participation in another clinical study with an investigational product during the last month
- Active systemic autoimmune diseases
- Hypersensitivity to the active ingredient or any of the excipients. Patients with Hereditary Fructose Intolerance
- Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months
- Positive hepatitis C antibodies, hepatitis B virus surface antigens at screening
- 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
- 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)
- Patients with or at risk of hypercalcaemia and/or hypomagnesaemia
- Known to have tested positive for human immunodeficiency virus
- 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
- Inability to fully understand the potential risks and benefits related to study participation
- Involvement in the study planning and/or conduct
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- Participants randomized to receive one 8.4 g packet of patiromer per dayTreatment being tested
Patiromer is an organic, non-absorbed, sodium-free, potassium-binding polymer that exchanges potassium for calcium in the gastrointestinal tract.
Treatment: Veltassa Oral Powder Product
- Participants randomized to receive one identical packet containing placeboPlacebo, for comparison
Active study treatment and placebo will be provided by Vifor Pharma and will be indistinguishable from one another in terms of labelling and instructions
Treatment: Placebo
Data and sources
- Registry record
- Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
- 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)
- Record updated
- 12 November 2024