A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) : A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease
This is a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) or stage 5 chronic kidney disease (CKD5) participants in Part 1, of multiple subcutaneous doses in CKD4 or CKD5 participants in Part 2, and of a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease in Part 3. The primary hypothesis is that, in Part 1, the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 or CKD5 participants is at least 11300 nM*hr..
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Klinische Studie| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
ClinicalTrials.gov - (2024) vom: 12. März Zur Gesamtaufnahme - year:2024 |
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| Sprache: |
Englisch |
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| Links: |
Volltext [kostenfrei] |
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| Themen: |
610 |
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| Anmerkungen: |
Source: Link to the current ClinicalTrials.gov record., First posted: December 19, 2022, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024 |
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| Study ID: |
NCT05656040 |
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| Veröffentlichungen zur Studie: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
CTG000012041 |
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| 245 | 1 | 0 | |a A Study of MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease (MK-2060-011) |b A Single-and Multiple Dose Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Subcutaneous MK-2060 in Participants With Chronic and/or End-Stage Kidney Disease |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: December 19, 2022, Last downloaded: ClinicalTrials.gov processed this data on March 20, 2024, Last updated: March 20, 2024 | ||
| 520 | |a This is a three-part study of MK-2060 in participants with chronic and/or end-stage kidney disease. The purpose of the study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single subcutaneous dose of MK-2060 in stage 4 chronic kidney disease (CKD4) or stage 5 chronic kidney disease (CKD5) participants in Part 1, of multiple subcutaneous doses in CKD4 or CKD5 participants in Part 2, and of a single subcutaneous dose of MK-2060 in participants with end-stage kidney disease in Part 3. The primary hypothesis is that, in Part 1, the true geometric mean of the area under the concentration-time curve from 0 to infinity (AUC0-inf) after a single-dose of MK-2060 in adult CKD4 or CKD5 participants is at least 11300 nM*hr. | ||
| 650 | 2 | |a Kidney Diseases | |
| 650 | 2 | |a Kidney Failure, Chronic | |
| 650 | 2 | |a Renal Insufficiency | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Recruiting | |
| 650 | 4 | |a Phase: Phase 1 | |
| 650 | 4 | |a 610 | |
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