Chronic Kidney Disease

Patiromer in the Treatment of Hyperkalemia in Patients With Hypertension and Diabetic Nephropathy (AMETHYST-DN)

NCT01371747 | PHASE 2 | INTERVENTIONAL

This study determined the optimal starting dose of patiromer in treating hyperkalemia in participants with hypertension and diabetic nephropathy who were already receiving ACEI and/or ARB drugs, with or without spironolactone. This study also evaluated the efficacy and safety of patiromer and the long term use of patiromer.

43 Sites

324 Participants

Recruiting

30 Years to 80 Years

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SUBMIT

Investigator Site

Karlovac,Croatia,47000

Investigator Site

Osijek,Croatia,31000

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Rijeka,Croatia,51000

Investigator Site

Zagreb,Croatia,10000

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Zagreb,Croatia,10000

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Zagreb,Croatia,10000

Investigator Site

Tbilisi,Georgia,0102

Investigator Site

Tbilisi,Georgia,0144

Investigator site

Tbilisi,Georgia,0159

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Tbilisi,Georgia,0159

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Tbilisi,Georgia,0159

Investigator Site

Tbilisi,Georgia,0159

Investigator Site

Tbilisi,Georgia,0159

Investigator Site

Tbilisi,Georgia,0159

Investigator Site

Tbilisi,Georgia,0159

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Tbilisi,Georgia,0159

Investigator Site

Tbilisi,Georgia,0186

Investigator Site

Budapest,Hungary,1097

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Budapest,Hungary,1106

Investigator Site

Budapest,Hungary,H-1041

Investigator Site

Budapest,Hungary,H-1097

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Budapest,Hungary,H-1115

Investigator Site

Gyor,Hungary,H-9024

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Hatvan,Hungary,3000

Investigator Site

Jaszbereny,Hungary,H-5100

Investigator Site

Kistarcsa,Hungary,H-2143

Investigator Site

Kisvarda,Hungary,4600

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Mosonmagyarovar,Hungary,H-9200

Investigator Site

Szekesfehervar,Hungary,H-8000

Investigator Site

Szikszo,Hungary,3800

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Veszprem,Hungary,H-8200

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Belgrade,Serbia,11000

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Belgrade,Serbia,11000

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Belgrade,Serbia,11000

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Belgrade,Serbia,11000

Investigator Site

Novi Sad,Serbia,21000

Investigator Site

Zrenjanin,Serbia,23000

Investigator Site

Celje,Slovenia,3000

Investigator Site

Golnik,Slovenia,4204

Investigator Site

Jesenice,Slovenia,4270

Investigator Site

Maribor,Slovenia,2000

Investigator Site

Slovenj Gradec,Slovenia,2380

Investigator Site

Šempeter pri Gorici,Slovenia,5290

Study Eligibility Criteria

Inclusion Criteria

1. Age 30 - 80 years old at screening (S1)
2. Type 2 diabetes mellitus (T2DM) diagnosed after age 30 which has been treated with oral medications or insulin for at least 1 year prior to S1
3. Chronic kidney disease (CKD): estimated glomerular filtration rate (eGFR) 15 - \< 60 mL/min/1.73m2 at screening based on central lab serum creatinine measurement (except for participants with hyperkalemia at S1), whose eligibility will be assessed based on local lab eGFR value)
4. Urine albumin/creatinine ratio (ACR):
1. Cohorts 1 and 2: urine ACR ≥ 30 mg/g at S1 AND average urine ACR ≥ 30 mg/g at the beginning of Run-In Period (R0) based on up to three ACR values obtained starting at S1 and ending at the R0 Visit
2. Cohort 3: not applicable
5. Local laboratory serum potassium (K+) values of:
1. Cohorts 1 and 2: 4.3 - 5.0 mEq/L at S1; AND 4.5 - 5.0 mEq/L at R0; AND \> 5.0 - \< 6.0 mEq/L at randomization to patiromer (Baseline, T0 Visit)
2. Cohort 3: \> 5.0 - \< 6.0 mEq/L at S1 OR at R0 after same day confirmation
6. Must be receiving an ACEI and/or ARB for at least 28 days prior to screening
7. Average systolic blood pressure (SBP) ≥ 130 - \< 180 mmHg AND average DBP ≥ 80 - \< 110 mmHg (sitting) at both screening and R0 (as applicable)
8. Females of child-bearing potential must be non-lactating, must have a negative serum pregnancy test at screening, and must have used a highly effective form of contraception for at least 3 months before patiromer administration, during the study, and for one month after study completion
9. Provide their written informed consent prior to participation in the study

Exclusion Criteria

1. Type 1 diabetes mellitus
2. Central lab hemoglobin A1c \> 12% at Screening 1 (S1) (except for Cohort 3 participants who are hyperkalemic at S1)
3. Emergency treatment for T2DM within the last 3 months
4. A confirmed SBP \> 180 mmHg or diastolic blood pressure (DBP) \> 110 mmHg at any time during SI or Run-In Period or at Baseline T0 Visit
5. Central lab serum magnesium \< 1.4 mg/dL (\< 0.58 mmol/L) at screening (Cohort 3 participants will be evaluated based on local lab serum magnesium measurement)
6. Central lab urine ACR ≥ 10000 mg/g at screening (except for Cohort 3 participants who are hyperkalemic at S1)
7. Confirmed diagnosis or history of renal artery stenosis (unilateral or bilateral)
8. Diabetic gastroparesis
9. Non-diabetic chronic kidney disease
10. History of bowel obstruction, swallowing disorders, severe gastrointestinal disorders or major gastrointestinal surgery (e.g., large bowel resection)
11. Current diagnosis of NYHA (New York Heart Association) Class III or IV heart failure
12. Body mass index (BMI) ≥ 40 kg/m2
13. Any of the following events having occurred within 2 months prior to screening: unstable angina as judged by the Principal Investigator (PI), unresolved acute coronary syndrome, cardiac arrest or clinically significant ventricular arrhythmias, transient ischemic attack or stroke, use of any intravenous cardiac medication
14. Prior kidney transplant, or anticipated need for transplant during study participation
15. Active cancer, currently on cancer treatment or history of cancer in the past 2 years except for non-melanocytic skin cancer which is considered cured
16. History of alcoholism or drug/chemical abuse within 1 year
17. Central lab liver enzymes \[alanine aminotransferase (ALT), aspartate aminotransferase (AST)\] \> 3 times upper limit of normal at S1 (except for Cohort 3 patients with hyperkalemia at S1, who will have local lab ALT and AST)
18. Loop and thiazide diuretics or other antihypertensive medications (calcium channel blocker, beta-blocker, alpha-blocker, or centrally acting agent) that have not been stable for at least 28 days prior to screening or not anticipated to remain stable during study participation
19. Current use of polymer-based drugs (e.g., sevelamer, sodium polystyrene sulfonate, colesevelam, colestipol, cholestyramine), phos

Additional Studies

Additional studies can be found at ClinicalTrials.gov