Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Patiromer Powder for Oral Suspension (Part A)
Patiromer · 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 | 4 | PHASE3 | Sodium zirconium cyclosilicate |
Patiromer for is being developed for the treatment of hyperkalemia, which is elevated potassium in the blood. The Phase 3 program studied it in adults with hyperkalemia and chronic renal insufficiency. It is a small molecule therapy in the nephrology therapeutic area.
Patiromer for is being developed by Fresenius Medical Care AG, which trades under the ticker FMS. The company sponsored the Phase 3 trial evaluating the drug in Chinese subjects with hyperkalemia and chronic renal insufficiency.
Patiromer for is in Phase 3 clinical development. The single registered trial, NCT05136664, was a Phase 3 study that has been completed. The drug is investigational and has not been approved for commercial use.
Patiromer for has been studied in one completed Phase 3 trial, NCT05136664, titled Trial Evaluating the Efficacy and Safety of Patiromer in Chinese Subjects. It enrolled 262 adults with hyperkalemia and chronic renal insufficiency in China and was randomized and placebo-controlled.
Yes, Patiromer for is also known as Patiromer Powder for Oral Suspension (Part A). Both names refer to the same investigational small molecule being developed by Fresenius Medical Care AG for hyperkalemia in patients with chronic renal insufficiency.