| Primary | Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria | Percentage of subjects developing AKI based on Serum Creatinine and/or Urine Output per KDIGO definition | | Posted | | Number | | percentage of subjects | | 72 hours | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Area Under the Curve (AUC) of Serum Creatinine (SCr) | Time-corrected area under the curve (AUC) of serum creatinine calculated as follows: The area under the SCr concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed SCr values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x SCr(12h) + 0.5 x SCr(24h) + 1 x SCr(48h) + 1 x SCr(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3 | | Posted | | Geometric Mean | 90% Confidence Interval | log(mg/dL)/day | | 72 hours | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Duration of AKI | Duration of AKI defined as the number of days meeting the definition of AKI (KDIGO definition) starting within 72 hours after first dose of IMP until resolution | | Posted | | Mean | Standard Deviation | Days | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Change in SCr Values Over Time | SCr at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90 | | Posted | | Mean | 90% Confidence Interval | mg/dL | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Peak Cystatin C Value | Change from baseline of peak cystatin C from baseline to Day 7 | | Posted | | Mean | 90% Confidence Interval | mg/L | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | AUC of Cystatin C | Time-corrected AUC of cystatin C for Day 1 to Day 4 (72 hours after first dose of IMP) calculated as follows: The area under the cystatin C concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed cystatin C values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x cystatin C(12h) + 0.5 x cystatin C(24h) + 1 x cystatin C(48h) + 1 x cystatin C(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3 | | Posted | | Geometric Mean | Standard Deviation | log(mg/L)/day | | 72 hours | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Number of Participants Requiring Renal Replacement Therapy (Dialysis) | Renal replacement therapy (dialysis treatment) required by any participant for any reason | | Posted | | Count of Participants | | Participants | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Number of Days Without Need for Dialysis | Number of days that participants were not requiring dialysis | | Posted | | Median | Inter-Quartile Range | Days | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Major Adverse Kidney Event (MAKE) - SCr | MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline. eGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr. | | Posted | | Number | | percentage of subjects | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | AKI Within 72 Hours Based on Cystatin C and UO | AKI based on cystatin C and/or urine output (UO) | | Posted | | Number | | percentage of subjects | | 72 hours | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | AKI Within 7 Days | AKI based on SCr and/or UO criteria, or cystatin C and/or UO criteria | | Posted | | Number | | percentage of subjects | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Persistence of AKI | AKI persistence, defined as an AKI (KDIGO definition) developing within 72 hours after first dose of IMP and with a duration of ≥72 hours | | Posted | | Number | | percentage of subjects | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Severity of AKI | AKI severity stage 1, 2 or 3 per KDIGO criteria, with 1 being mildest stage and 3 being most severe stage. Reference: KDIGO (2012). "Clinical Practice Guideline for Acute Kidney Injury." JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY 2(1). | | Posted | | Number | | percentage of participants with AKI | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Change in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR) | Post-baseline changes in UACR and UPCR at Day 4, Day 30, and Day 90 | | Posted | | | | | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing will be based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Pharmacokinetics of RMC-035 (AUC) | AUC(0-24) of RMC-035 concentrations in plasma (Day 3) | | Posted | | Mean | Standard Deviation | h*ug/mL | | 4 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion |
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| Secondary | Pharmacokinetics of RMC-035 (Cmax) | Cmax of RMC-035 concentrations in plasma Day 3 | | Posted | | Mean | Standard Deviation | ug/mL | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion |
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| Secondary | Presence of Anti-drug Antibodies (ADA) | Presence of ADA at Day 1 (pre-surgery), Day 30, and Day 90; positive samples | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Characteristics of ADA (Cross-reactivity) | Characteristics of ADA developed at Day 30 and Day 90 with regards cross-reactivity with endogenous alpha-1-microglobulin (A1M) | | Posted | | Count of Participants | | Participants | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Peak SCr Value | Change from baseline of peak SCr from baseline to Day 7 | | Posted | | Mean | 90% Confidence Interval | mg/dL | | 7 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Major Adverse Kidney Event (MAKE) - Cystatin C | MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline. eGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using Cystatin C. | | Posted | | Number | | percentage of subjects | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Major Adverse Kidney Event (MAKE) - SCr and Cystatin C | MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline. eGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr and Cystatin C. | | Posted | | Number | | percentage of subjects | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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| Secondary | Change in Serum Cystatin C Values Over Time | Cystatin C measurement in serum at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90 | | Posted | | Mean | 90% Confidence Interval | mg/L | | 90 days | | | | ID | Title | Description |
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| OG000 | RMC-035 | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing was done per kg bodyweight and at Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. RMC-035: Concentrate for Solution for Infusion | | OG001 | Placebo | Identical to RMC-035 arm except that the placebo contains no active ingredient. Placebo: Concentrate for Solution for Infusion |
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