Phase 2
Completed N=178
Extension Study Of Subjects From Study A3921030 For The Prevention Of Acute Rejection In Kidney Transplant Patients
Source: ClinicalTrials.gov NCT00658359 ↗Enrolled (actual)
178
Serious AEs
57.9%
Results posted
Feb 2018
Primary outcomePrimary: Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit — 4.69; 8.33; 3.70; 7.81 Percentage of Participants — p=0.6694
Summary
This is a study that will follow transplant patients from Study A3921030 to monitor for long term safety, tolerability and efficacy for 5 additional years, except in Portugal where the study will follow transplant patients through Month 36 posttransplant. Patients will continue their study medications that were previously assigned.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Kaplan-Meier Analysis of Percentage of Participants With Clinically Significant Infection by Visit |
4.69; 8.33; 3.70; 7.81; 10.00; 18.52 | 0.6694 |
| PRIMARY Percentage of Participants With Malignancies |
10.9; 13.3; 14.8 | 0.683 |
| PRIMARY Least Squares Means of Measured Glomerular Filtration Rate (GFR) (Iohexol Serum Clearance in Milliliters Per Minute [mL/Min]) |
67.63; 76.86; 75.86 | 0.0699 |
| PRIMARY Percentage of Participants With Progression of Chronic Allograft Lesions at Month 36 |
87.50; 77.78; 87.50 | — |
| PRIMARY Kaplan-Meier Analysis of Percentage of Participants With First Biopsy Proven Acute Rejection (BPAR) by Visit |
6.25; 10.00; 5.56; 7.81; 10.00; 7.41 | 0.6694 |
| PRIMARY Kaplan-Meier Analysis of Percentage of Participants With Treated Clinical Acute Rejection by Visit |
14.06; 6.67; 9.26; 17.19; 6.67; 11.11 | 0.0654 |
| SECONDARY Kaplan-Meier Analysis of Percentage of Participants With Efficacy Failure by Visit |
6.25; 10.00; 5.56; 7.81; 10.00; 9.26 | 0.6694 |
| SECONDARY Kaplan-Meier Analysis of Percentage of Participants With Combined Banff Rejection by Visit |
15.63; 13.33; 11.11; 20.31; 13.33; 16.67 | 0.2957 |
| SECONDARY Kaplan-Meier Analysis of Percent of Participants With Graft Survival With Death Censored by Visit |
100.00; 100.00; 100.00; 100.00; 100.00; 100.00 | 0.3132 |
| SECONDARY Kaplan-Meier Analysis of Percentage of Participants Surviving by Visit |
100.00; 100.00; 100.00; 100.00; 100.00; 98.15 | 0.3128 |
| SECONDARY Percentage of Participants Discontinuing From the Study |
43.8; 75.0; 85.2 | — |
| SECONDARY Least Squares Means of Total Serum Cholesterol Levels (Milligrams Per Deciliter [mg/dL]) by Visit |
199.14; 213.49; 196.27; 200.51; 212.67; 193.50 | 0.0786 |
| SECONDARY Least Squares Means of Total Serum Low Density Lipoprotein (LDL) Cholesterol Levels (mg/dL) by Visit |
113.09; 119.71; 108.72; 112.82; 119.36; 109.87 | 0.3139 |
| SECONDARY Least Squares Means of Total Serum High Density Lipoprotein (HDL) Cholesterol Levels (mg/dL) by Visit |
49.88; 59.67; 55.20; 50.47; 59.87; 55.78 | <0.0001 sig |
| SECONDARY Least Squares Means of Total Serum Triglycerides (mg/dL) by Visit |
177.33; 171.21; 167.38; 181.92; 163.26; 145.05 | 0.7543 |
| SECONDARY Mean Absolute Neutrophil Counts (ANC) (Kelvin Per Millimeter Cubed [K/mm^3]) by Visit |
4.53; 4.23; 4.33; 4.59; 3.87; 4.83 | — |
| SECONDARY Mean Hemoglobin (Hgb) (Grams Per Deciliter [g/dL]) by Visit |
13.20; 13.14; 13.35; 13.15; 13.31; 13.50 | — |
| SECONDARY Mean Glycosylated Hemoglobin (HBA1c) (Percent [%]) by Visit |
6.35; 6.16; 6.37; 6.16; 5.92; 6.69 | — |
| SECONDARY Least Squares Means of Fasting Serum Glucose Levels (mg/dL) by Visit |
104.42; 102.10; 107.18; 113.01; 106.17; 107.56 | 0.7693 |
| SECONDARY Percentage of Participants by Proteinuria Category by Visit |
15.7; 27.7; 19.4; 3.9; 6.4; 8.3 | — |
| SECONDARY Least Square Means of Estimated GFR Calculated Using the Nankivell Equation by Visit |
69.57; 82.33; 82.96; 70.93; 82.41; 82.91 | <0.0001 sig |
| SECONDARY Least Squares Means of Estimated GFR Calculated Using the Cockcroft-Gault Equation by Visit |
72.74; 87.22; 87.67; 73.56; 87.52; 87.12 | 0.0010 sig |
| SECONDARY Least Squares Means of Estimated GFR (eGFR) (mL/Min/1.73 Square Meter [m^2]) Calculated by the Modification of Diet in Renal Disease (MDRD) Equation With Last Observation Carried Forward (LOCF) Plus Imputation (eGFR=0 for Graft Loss/Death) by Visit |
56.25; 72.12; 70.22; 58.13; 71.66; 69.69 | <0.0001 sig |
| SECONDARY Least Squares Means of Short Form 36 Version 2 (SF-36 V2) Component and Domain Scores at Months 24 and 36 |
49.04; 47.00; 45.47; 46.36; 47.72; 44.40 | 0.2393 |
| SECONDARY Least Squares Means of End-Stage Renal Disease (ESRD) Symptom Checklist (SCL) -Transplantation Modules at Months 24 and 36 |
0.59; 0.70; 0.71; 0.63; 0.71; 0.75 | 0.3093 |
| SECONDARY Least Squares Means of Severity of Dyspepsia Assessment (SODA) Subscales at Months 24 & 36 |
9.51; 7.66; 10.73; 11.44; 11.24; 12.25 | 0.2826 |
| SECONDARY Mean Trough Levels of Tofacitinib by Visit |
13.20; 10.68; 12.45; 15.27; 56.62; 56.58 | — |
| SECONDARY Mean Trough Levels of Cyclosporine by Visit |
113.88; 89.52; 101.10; 88.54; 95.00; 135.30 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects who successfully completed Study A3921030
Exclusion Criteria
- Subjects who are on the waiting list for a second kidney transplant or any non-renal organ transplants
Data sourced from ClinicalTrials.gov (NCT00658359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.