HyperkalemiaPhase 4TACPATNCT05029310
Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients
A Phase 4 study testing Patiromer Oral Product in people with Hyperkalemia and Kidney Transplant, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Patiromer lowers potassium effectively in patients with hyperkalemia and chronic kidney disease. Patients with a kidney transplant usually have reduced renal function and may also develop hyperkalemia. However, potential interactions between immunosuppressive medications and patiromer have not been evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperkalemia, Kidney Transplant
- What is being tested?
- Patiromer Oral Product
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteNorway
- Study dates
- 1 Sep 2021to 1 Feb 2023
- Phase
- Phase 4
- 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
- Renal transplant recipients, at least 3 weeks after transplantation, who receive Tacrolimus as part of their immunosuppressive therapy, with stabile tacrolimus dose and trough tacrolimus concentration.
- Recipients 18 years of age or older.
- Hyperkalemia (K>5 and <6,0)
- Signed informed consent.
Who cannot join
- Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, resonium-calcium, and/or sodium zirconium cyclosilicate.
- Constipation, defined as fewer than three bowel movements per week.
- Hypomagnesemia less than 0.6 mmol/L.
- Serum potassium level of greater than 6.0 mEq/L.
- Increased immunologic risk patient (DSA, ABO-incompatible transplant).
- Pregnancy or suspected pregnancy (pregnancy is excluded at time of transplantation by measuring HCG, kidney transplanted patients should not become pregnant before at least one year after transplant, and no transplanted patient has ever become pregnant during the first weeks after transplantation. They are all informed regarding different types of contraception). Fertile women will be tested for pregnancy before inclusion.
- Hypersensitivity/allergy to patiromer.
- Other serious medical or psychiatric condition likely to interfere with participation.
Trial locations and contacts
1 site in 1 country.
About this study
Patiromer lowers potassium effectively in patients with hyperkalemia and chronic kidney disease. Patients with a kidney transplant usually have reduced renal function and may also develop hyperkalemia. However, potential interactions between immunosuppressive medications and patiromer have not been evaluated. These interactions could involve change in AUC of immunosuppressive drugs, such as calcineurin inhibitors or mycophenolate, or increased risk of hypomagnesemia, since both tacrolimus and patiromer have this potential side effect. We wish to evaluate potential interactions to ensure safe use of this drug in the transplant population.
Read the detailed description
Patients with a kidney transplant may develop hyperkalemia. This could be due to different mechanisms. In some patients it could be due to reduced kidney function. In others, it could be secondary to renal tubular acidosis type 4 caused by necessary medications used after transplantation.
The most important medicines contributing to hyperkalemia after kidney transplantation are calcineurin inhibitors which are a compulsory part of the immunosuppressive regimen, ACE inhibitors or ARBs in patients with hypertension, and trimethoprim-sulfa, which is used as infection prophylaxis in all patients during the first 6 months after transplantation. In the weeks after renal transplantation around 5-10% of transplant patients at our institution at some point develop hyperkalemia above the limit where some type of management of hyperkalemia would be indicated. As the drugs mentioned above can rarely or not at all be withdrawn after transplantation, most doctors will either observe the hyperkalemia untreated or try to lower the potassium level.
In outpatients with s-potassium of 5 - 6.5, urgent management is usually not necessary. However, some kind of intervention is still indicated, to make sure that the potassium will decrease during the next days. Patiromer could be an interesting alternative in those kidney transplanted patients that are in this category. We are not aware of any published studies describing the use of patiromer in the transplant population. We intend to investigate if there is any pharmacokinetic interaction between patiromer and immunosuppressive drugs affecting the blood concentration of the latter.
- Conditions
- Hyperkalemia, Kidney Transplant
- Being tested
- Patiromer Oral Product
- Keywords
- kidney transplant, Hyperkalemia
- Medical subject headings
- Hyperkalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patiromer Oral ProductDrug
interaction study
| Study group | Role | What they receive |
|---|---|---|
| All patients use both patiromer and tacrolimus | Experimental | Pharmacokinetic investigation of tacrolimus performed in both the presence and absence of patiromer for all patients. Receives: Drug: Patiromer Oral Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
study potential interaction between patiromer and tacrolimus
Log-transformed AUC0-tau of tacrolimus between patiromer vs. no patiromer
Measured: two weeks
Secondary outcomes (1)
Determine effect of patiromer on potassium concentration.
Delta-value change of serum potassium from start of treatment to 7 days after start of treatment, and delta-value change of serum potassium from 7 days after start of treatment to 7 days after end of treatment.
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2021
- Study start1 Sep 2021
- Primary completion1 Feb 2023
- Study completion1 Feb 2023
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 Oslo University 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients already taking tacrolimus start treatment with patiromer. After seven days tacrolimus kinetics are studied. Seven days after discontinuation of patiromer, tacrolimus kinetics are repeated.
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geir Mjøen, Oslo University Hospital
- Investigators
- Geir Mjøen, MD, Principal investigator, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05029310
- Sponsor's protocol ID
- 148684
- Acronym
- TACPAT
- Status last verified
- Mar 2023
- First submitted
- 26 Aug 2021
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Patiromer on Pharmacokinetics of Immunosuppresive Drugs in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT05029310
- Acronym / sponsor ID
- TACPAT / 148684
- Conditions
- Hyperkalemia, Kidney Transplant
- Keywords
- kidney transplant, Hyperkalemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 1 Feb 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 31 Aug 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.
Patiromer lowers potassium effectively in patients with hyperkalemia and chronic kidney disease. Patients with a kidney transplant usually have reduced renal function and may also develop hyperkalemia. However, potential interactions between immunosuppressive medications and patiromer have not been evaluated. These interactions could involve change in AUC of immunosuppressive drugs, such as calcineurin inhibitors or mycophenolate, or increased risk of hypomagnesemia, since both tacrolimus and patiromer have this potential side effect. We wish to evaluate potential interactions to ensure safe use of this drug in the transplant population.
Detailed description
Patients with a kidney transplant may develop hyperkalemia. This could be due to different mechanisms. In some patients it could be due to reduced kidney function. In others, it could be secondary to renal tubular acidosis type 4 caused by necessary medications used after transplantation.
The most important medicines contributing to hyperkalemia after kidney transplantation are calcineurin inhibitors which are a compulsory part of the immunosuppressive regimen, ACE inhibitors or ARBs in patients with hypertension, and trimethoprim-sulfa, which is used as infection prophylaxis in all patients during the first 6 months after transplantation. In the weeks after renal transplantation around 5-10% of transplant patients at our institution at some point develop hyperkalemia above the limit where some type of management of hyperkalemia would be indicated. As the drugs mentioned above can rarely or not at all be withdrawn after transplantation, most doctors will either observe the hyperkalemia untreated or try to lower the potassium level.
In outpatients with s-potassium of 5 - 6.5, urgent management is usually not necessary. However, some kind of intervention is still indicated, to make sure that the potassium will decrease during the next days. Patiromer could be an interesting alternative in those kidney transplanted patients that are in this category. We are not aware of any published studies describing the use of patiromer in the transplant population. We intend to investigate if there is any pharmacokinetic interaction between patiromer and immunosuppressive drugs affecting the blood concentration of the latter.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients already taking tacrolimus start treatment with patiromer. After seven days tacrolimus kinetics are studied. Seven days after discontinuation of patiromer, tacrolimus kinetics are repeated.
| Arm | Type | Receives |
|---|---|---|
| All patients use both patiromer and tacrolimus | Experimental | Drug: Patiromer Oral ProductPharmacokinetic investigation of tacrolimus performed in both the presence and absence of patiromer for all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Renal transplant recipients, at least 3 weeks after transplantation, who receive Tacrolimus as part of their immunosuppressive therapy, with stabile tacrolimus dose and trough tacrolimus concentration.
- Recipients 18 years of age or older.
- Hyperkalemia (K>5 and <6,0)
- Signed informed consent.
Key exclusion criteria (8 listed)
- Concomitant treatment with: diltiazem, verapamil, fenytoin, carbamazapin, fluconazole, ketoconazole, vorikonazole, erythromycin, clarithromycin, resonium-calcium, and/or sodium zirconium cyclosilicate.
- Constipation, defined as fewer than three bowel movements per week.
- Hypomagnesemia less than 0.6 mmol/L.
- Serum potassium level of greater than 6.0 mEq/L.
- Increased immunologic risk patient (DSA, ABO-incompatible transplant).
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 |
|---|---|---|
| Patiromer Oral Productinteraction study | Drug | All patients use both patiromer and tacrolimus |
Primary outcome
study potential interaction between patiromer and tacrolimus
Time frame: two weeks
Log-transformed AUC0-tau of tacrolimus between patiromer vs. no patiromer
1 secondary outcome
Determine effect of patiromer on potassium concentration.
Time frame: two weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2023.
- Individual participant dataSharing planned: No. no plan
Related trials for Hyperkalemia
Enrolling by invitationObservational study
AK+ Guard™ Pilot Study in Chronic Kidney Disease: Outpatient Diagnostic Accuracy and Remote Monitoring
Hyperkalemia, Chronic Kidney Disease (Stage 3-4)
Not yet recruiting
Effects of Minimally vs. Ultra-Processed Diets on Potassium (K) Handling in CKD
Chronic Kidney Disease
RecruitingPhase 3
A Phase 3 Study Evaluating the Efficacy and Safety of WS016 for the Treatment of Hyperkalemia
Hyperkalemia
Enrolling by invitationPhase 4
Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)
Chronic Kidney Disease, Type 2 Diabetes
Recruiting
Safety of a Healthy Plant-based Diet With Higher Potassium Content, Compared to a Healthy Plant-based Diet With Limited Potassium Content in Patients With Chronic Kidney Disease: A Pilot Study
Hyperkalemia, Chronic Kidney Disease (Stages 4 and 5)
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.
Geir Mjøen, MD principal investigator
MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Patiromer Oral Product in people with Hyperkalemia and Kidney Transplant, run by Oslo University Hospital at 1 site in Norway.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 23 Mar 2023. 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 Norway. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
study potential interaction between patiromer and tacrolimus (time frame: two weeks). 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 23 Mar 2023.