Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Patiromer for · 1 trial · 2 indications
Measured in milliequivalents per litre (mEq/L)
Measured in mEq/L
| Arm | Type | Description |
|---|---|---|
| Part A: Patiromer | EXPERIMENTAL | Part A: 4-week, single-arm patiromer treatment phase (4 weeks) |
| Part B: Placebo | PLACEBO_COMPARATOR | Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase |
| Part B: Patiromer | EXPERIMENTAL | Part B: 8-week randomized, parallel group, placebo-controlled withdrawal phase |
| Name | Type | Description |
|---|---|---|
| Patiromer Powder for Oral Suspension (Part A) | DRUG | Participants initiate patiromer at an oral dose of 1 packet/day (8.4g/day as powder for suspension). The dose is adjusted ate the following visit based on local serum potassium (sK+) levels. The content of each packet should be mixed with water, apple or cranberry juice before administration. |
| Placebo (Part B) | DRUG | Placebo is provided in packets, each containing 6 g of placebo as powder for suspension. Participants will take 1 packet per day, by mixing its content with water, apple or cranberry juice. |
| Patiromer Powder for Orals Suspension (Part B) | DRUG | Participants will continue to receive the same number of packets established during Part A, but dose may be up- or down titrated depending on sK+ levels. The content of each packet should be mixed with water, apple or cranberry juice before administration. |
Inclusion Criteria: * \- Chinese subjects at least 18 years of age. * \- Chronic Kidney Disease (CKD) stage 3 and 4. * \- Mean of 2 measurement of serum potassium higher than 5.0 and lower than 6.5 mEq/L at baseline. * \- Subjects on any stable dose of at least 1 RAASi medication for at least 28 da...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 3 | PHASE3 | Zirconium Cyclosilicate Reduced Dose Level, Zirconium Cyclosilicate Dose Level 1, Zirconium Cyclosilicate Dose During 28 Day Maintenance Phase |
Patiromer is used for hyperkalemia, a condition of elevated potassium levels in the blood. It is being developed for patients with chronic renal insufficiency who have hyperkalemia. The drug is currently in Phase 3 clinical development and is not yet approved for this use.
Patiromer is being developed by Fresenius Medical Care AG, a company traded on the New York Stock Exchange under the ticker symbol FMS. The company is conducting clinical trials to evaluate the efficacy and safety of patiromer in patients with hyperkalemia and chronic renal insufficiency.
Patiromer is in Phase 3 clinical development. A Phase 3 trial has been completed, and the drug remains investigational, meaning it has not been approved by regulatory authorities. The completed trial enrolled 262 participants with hyperkalemia and chronic renal insufficiency.
Patiromer has one completed Phase 3 clinical trial with the identifier NCT05136664, titled 'Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects.' The trial enrolled 262 participants with hyperkalemia and chronic renal insufficiency in China. The trial was randomized and placebo-controlled.
Patiromer is not FDA approved. It is an investigational drug currently in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug has not received regulatory approval for the treatment of hyperkalemia.