Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan : A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan
This study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with FSGS who are already taking irbesartan by:monitoring symptoms that participants may experience while on the study,measuring levels of protein in participant's urine and kidney function during the course of the study,measuring the levels of propagermanium and irbesartan that enters into participant's urine and blood, andcomparing the propagermanium outcomes to participants' pre-study and placebo outcomes.Eligible participants will randomly be assigned to one of two arms to receive both the propagermanium and placebo in different orders as follows, either:Treatment Period 1 taking a propagermanium capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day for 16 weeks.OR Treatment Period 1 taking a placebo capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a day for 16 weeks..
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Klinische Studie| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
ClinicalTrials.gov - (2022) vom: 29. Juli Zur Gesamtaufnahme - year:2022 |
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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: August 28, 2018, Last downloaded: ClinicalTrials.gov processed this data on August 01, 2022, Last updated: August 03, 2022 |
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| Study ID: |
NCT03649152 |
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| Veröffentlichungen zur Studie: |
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| PPN (Katalog-ID): |
CTG002824140 |
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| 245 | 1 | 0 | |a Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan |b A Phase 2a, Double-Blind, Randomized, Placebo-Controlled, Crossover Study Evaluating the Safety and Efficacy of Propagermanium in Patients With Primary Focal Segmental Glomerulosclerosis (FSGS) Who Are Receiving Irbesartan |
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| 500 | |a Source: Link to the current ClinicalTrials.gov record., First posted: August 28, 2018, Last downloaded: ClinicalTrials.gov processed this data on August 01, 2022, Last updated: August 03, 2022 | ||
| 520 | |a This study will be evaluating the safety and efficacy of propagermanium for the treatment of participants with FSGS who are already taking irbesartan by:monitoring symptoms that participants may experience while on the study,measuring levels of protein in participant's urine and kidney function during the course of the study,measuring the levels of propagermanium and irbesartan that enters into participant's urine and blood, andcomparing the propagermanium outcomes to participants' pre-study and placebo outcomes.Eligible participants will randomly be assigned to one of two arms to receive both the propagermanium and placebo in different orders as follows, either:Treatment Period 1 taking a propagermanium capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a placebo capsule twice a day for 16 weeks.OR Treatment Period 1 taking a placebo capsule twice a day for 16 weeks, followed by a six week washout period followed by Treatment Period 2 taking a propagermanium capsule twice a day for 16 weeks. | ||
| 650 | 2 | |a Glomerulosclerosis, Focal Segmental | |
| 650 | 4 | |a Medical Condition: Focal Segmental Glomerulosclerosis | |
| 650 | 4 | |a Study Type: Interventional | |
| 650 | 4 | |a Recruitment Status: Completed | |
| 650 | 4 | |a Phase: Phase 2 | |
| 650 | 4 | |a 610 | |
| 773 | 0 | 8 | |i Enthalten in |t ClinicalTrials.gov |g (2022) vom: 29. Juli |
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