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  • HP:0000794: IgA deposition in the glomerulus
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    HP:0000794: IgA deposition in the glomerulus

    Developed by Shray Alag, The Harker School
    Sections: Correlations, Clinical Trials, and HPO

    Correlations computed by analyzing all clinical trials.

    Navigate: Clinical Trials and HPO


    Correlated Drug Terms (2)


    Name (Synonyms) Correlation
    drug2088 LNP023 Wiki 1.00
    drug2916 Placebo Wiki 0.04

    Correlated MeSH Terms (2)


    Name (Synonyms) Correlation
    D005922 Glomerulonephritis, IGA NIH 1.00
    D007674 Kidney Diseases NIH 0.27

    Correlated HPO Terms (1)


    Name (Synonyms) Correlation
    HP:0000077 Abnormality of the kidney HPO 0.27

    Clinical Trials

    Navigate: Correlations   HPO

    There is one clinical trial.


    1 A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase III Study to Evaluate the Efficacy and Safety of LNP023 in Primary IgA Nephropathy Patients

    The study is designed as a multicenter, randomized , double-blind, placebo controlled study to demonstrate the superiority of LNP023 at a dose of 200 mg b.i.d. compared to placebo on top of maximally tolerated ACEi or ARB on reduction of proteinuria and slowing renal disease progression in primary IgA Nephropathy patients.

    NCT04578834
    Conditions
    1. IgA Nephropathy
    Interventions
    1. Drug: Placebo
    2. Drug: LNP023
    MeSH:Kidney Diseases Glomerulonephritis, IGA
    HPO:Abnormality of the kidney IgA deposition in the glomerulus Nephropathy

    Primary Outcomes

    Description: Evaluated at interim analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein to Creatinine Ratio sampled from a 24h urine collection.

    Measure: Ratio to baseline in Urine Protein to Creatinine Ratio (sampled from 24h urine collection) at 9 months

    Time: Baseline and 9 months

    Description: Evaluated at the final analysis - to demonstrate superiority of LNP023 vs. placebo in slowing renal disease progression measured by the annualized total slope of Estimated Glomerular Filtration Rate (eGFR) change over 24 months.

    Measure: Annualized total Estimated Glomerular Filtration Rate (eGFR) slope estimated over 24 months).

    Time: Baseline and 24 months

    Secondary Outcomes

    Description: Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.

    Measure: Proportion of participants reaching Urine Protein To Creatinine Ratio <1g/g at 9 months, without receiving Corticosteroids/Immunosuppressant or other newly approved drugs for treatment of IgAN or initiating Renal Replacement Therapy.

    Time: Baseline and 9 months

    Description: Evaluated at interim analysis - To evaluate the effect of LNP023 vs. placebo on slowing renal disease progression measured by the annualized total slope of Estimated Glomerular Filtration Rate change over 1 year.

    Measure: Annualized total Estimated Glomerular Filtration Rate slope estimated over 12 months

    Time: Baseline and 12 months

    Description: Evaluated at interim analysis - To assess the effect of LNP023 vs. placebo on the change from baseline to 9 months in fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

    Measure: Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire

    Time: Baseline and 9 months

    Description: Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on delaying the time to first occurrence of a composite renal endpoint of reaching either at least 30% change in Estimated Glomerular Filtration Rate, End-Stage Renal Disease or renal death.

    Measure: Time from randomization to first occurrence of composite renal endpoint event, defined as reaching either ≥30% decline in Estimated Glomerular Filtration Rate (eGFR) relative to baseline, or End Stage Renal Disease (ESRD), or renal death

    Time: Up to 24 months

    Description: Evaluated at final analysis - To demonstrate superiority of LNP023 vs. placebo in the change of proteinuria at 9 months by measuring Urine Protein To Creatinine Ratio sampled from a 24h urine collection.

    Measure: Ratio to baseline in Urine Protein-To-Creatinine Ratio (sampled from 24h urine collection) at 9 months

    Time: Baseline and 9 months

    Description: Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the proportion of study participants reaching proteinuria below 1g/g of Urine Protein To Creatinine Ratio (sampled from 24h urine collection) at 9 months.

    Measure: Proportion of participants reaching Urine Protein-To-Creatinine Ratio <1g/g at 9 months without receiving Corticosteroids/Immunosuppressant Therapy or other newly approved drugs for treatment of IgAN or initiating renal replacement therapy

    Time: Baseline and 9 months

    Description: Evaluated at final analysis - To demonstrate the superiority of LNP023 vs. placebo on the change from baseline to 9 months in the fatigue scale measured by Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

    Measure: Change from baseline to 9 months in the fatigue scale measured by the Functional Assessment Of Chronic Illness Therapy-Fatigue questionnaire.

    Time: Baseline and 9 months

    HPO Nodes


    HPO

    Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials

    Reports

    Data processed on September 26, 2020.

    An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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