| Primary | Ratio of Urine Protein to Creatine Ratio (UPCR) at 9 Months Compared to Baseline | The outcome is measured as UPCR based on 24 hour urine collections at 9 months following the first dose of Nefecon compared to baseline Ratio being: UPCR at 9 months in g/gram divided with UPCR at Baseline in g/gram | Number of participants analyzed reflects number of patients with available data at baseline and 9 months . | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | ratio | | 9 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG0000.67(0.56 to 0.80)
- OG0010.69(0.60 to 0.80)
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| Primary | Ratio of Estimated Glomerular Filtration Rate (eGFR) at 9 Months Compared to Baseline | The outcome is measured as ratio of eGFR in mL/min/1.73 m2 (calculated using the CKD-EPI formula) at 9 months following the first dose of Nefecon compared to baseline. I.e. eGFR at 9 months divided by eGFR at Baseline. | | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | ratio | | 9 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Ratio of Urine Albumin to Creatinine Ratio (UACR) at 9 Months Compared to Baseline | Ratio of urine albumin to creatinine ratio (UACR) measured by 24h urine sampling at 9 months compared to baseline. I.e. UACR at 9 months divided by eGFR at Baseline. | | Posted | | Geometric Least Squares Mean | 95% Confidence Interval | ratio | | 9 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Change From Baseline Short Form 36 (SF-36) Quality of Life Assessment at 12 Months | Short Form 36 (SF-36) quality of life assessment at 12 months compared to baseline, i.e. change from baseline. The 36-Item Short Form Health Survey (SF-36) is a set of generic, coherent, and easily administered quality-of-life measures. These measures rely upon patient self-reporting and have been widely used. It consists of eight health concepts: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Higher scores indicate better health. Scores represent the percentage of total possible score achieved, i.e. 0 is the minimum and 100 is the maximum score. | | Posted | | Mean | Standard Deviation | Change in percentage of total Score | | Baseline & 12 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Number of Patients With Microhematuria at 9 Months Compared to Baseline | | | Posted | | Count of Participants | | Participants | | 9 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Number of Patients Receiving Rescue Treatment | Systemic immunosuppressive drugs (including glucocorticoids in some situations ), dialysis, and renal transplantation are considered as rescue medications in this study. | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Proportion of Patients on Dialysis, Undergoing Kidney Transplantation, or With eGFR <15 mL/Min Per 1.73 m2 | Looking at number of patients with end stage kidney disease defined as being on dialysis, undergoing kidney transplantation, or having eGFR <15 mL/min per 1.73 m2 | | Posted | | Count of Participants | | Participants | | 12 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Change From Baseline Cortisol Suppression at 9 Months | Cortisol suppression at 9 and 12 months, measured as urinary cortisol excretion over 24 hours compared to baseline. | | Posted | | Mean | Standard Deviation | ug/day) | | Baseline & 9 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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| Secondary | Change From Baseline Cortisol Suppression at 12 Months | Cortisol suppression at 9 and 12 months, measured as urinary cortisol excretion over 24 hours compared to baseline. | | Posted | | Mean | Standard Deviation | ug/day | | Baseline & 12 months | | | | ID | Title | Description |
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| OG000 | Retreatment - Previously Treated With Nefecon in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. | | OG001 | Delayed Treatment - Previously Treated With Placebo in Nef-301 Study | Nef-301-OLE study is an extension study to the Nef-301 study. Study results are analyzed based on treatment in the previous Nef-301 study where patients were randomized to receive either Nefecon or Placebo. Thus, in this Nef-301-OLE study the patients are either retreated with Nefecon or receiving Nefecon for the first time. |
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