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Propagermanium

Phase 2

Diabetic Kidney Disease | Small molecule | Nephrology |IQVIA Holdings, Inc.|Last Updated: Jul 29, 2022

Success Probability

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment45

FDA Designations

No designations recorded

Clinical trial landscape

Propagermanium · 2 trials · 2 indications

Phase 2 2
NCT03649152Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving IrbesartanFocal Segmental Glomerulosclerosis
COMPLETED8 Analytics
NCT03627715Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving IrbesartanDiabetic Kidney Disease
COMPLETED45 Analytics
PHASE2COMPLETED
Safety and Effectiveness of Propagermanium in Focal Segmental Glomerulosclerosis Participants Receiving Irbesartan
Focal Segmental GlomerulosclerosisUnlock trial analytics
PHASE2COMPLETED
Safety and Effectiveness of Propagermanium in Diabetic Kidney Disease Participants Receiving Irbesartan
Diabetic Kidney DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

The Number of Adverse Events with the Adjunct use of Propagermanium Compared to Placebo in Participants with FSGS who are Receiving Irbesartan
Sixteen weeks

Assessed by monitoring of adverse events

The Change in Albumin/Creatinine Ratio with Adjunct use of Propagermanium Compared to Placebo in Participants with DKD who are Receiving Irbesartan
Twelve weeks

Assessed by measuring albumin/creatinine ratio.

Secondary Endpoints

The Frequency of Proteinuria-Based Responses to Treatment Compared to Placebo
Sixteen weeks
The Effect of Treatment with Propagermanium Compared to Placebo on Measures of Estimated Glomerular Filtration Rate
Twelve weeks
The Number of Adverse Events with the Adjunct use of Propagermanium
Twelve weeks
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Propagermanium then PlaceboEXPERIMENTALPropagermanium one capsule orally twice daily for 16 weeks. Compliance will be measured by drug accountability and completion of a participant diary. Participants will receive 16 weeks propagermanium and 16 weeks placebo separated by a 6 week washout period.
Placebo then PropagermaniumEXPERIMENTALPropagermanium one capsule orally twice daily for 16 weeks. Compliance will be measured by drug accountability and completion of a participant diary. Participants will receive 16 weeks placebo and 16 weeks propagermanium separated by a 6 week washout period.

Interventions

NameTypeDescription
PropagermaniumDRUGImmediate release capsule
PlaceboDRUGPlacebo capsule
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites11

Inclusion Criteria: 1. Aged 18 to 80 (inclusive) at screening; 2. A diagnosis of primary FSGS confirmed by renal biopsy; 3. Must be receiving a stable dose of 300 mg daily dose of irbesartan (in any marketed formulation) for at least 3 months prior to screening, and have no plan to change treatment...

Countries:Australia
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Frequently asked questions about Propagermanium

What is Propagermanium used for?

Propagermanium is an investigational small molecule being studied for Diabetic Kidney Disease and Focal Segmental Glomerulosclerosis. It is in Phase 2 clinical development. It is not approved by the FDA and remains under investigation for these kidney conditions.

Who is developing Propagermanium?

Propagermanium is being developed by IQVIA Holdings, Inc., which trades under the ticker IQV. The company is conducting clinical trials for the drug in nephrology indications.

What phase is Propagermanium in?

Propagermanium is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. Clinical trials for the drug have been completed, and it is not currently in active trials.

What clinical trials is Propagermanium in?

Propagermanium has been studied in two completed Phase 2 trials. NCT03627715 evaluated the drug in Diabetic Kidney Disease participants receiving Irbesartan, with 45 enrolled. NCT03649152 evaluated it in Focal Segmental Glomerulosclerosis participants receiving Irbesartan, with 8 enrolled.

Is Propagermanium the same as other names?

No alternative names for Propagermanium have been reported. The drug is referred to by its generic name, Propagermanium, in clinical trial records and development documentation.