Trial Outcomes & Findings for Rituximab to Prevent Recurrence of Proteinuria (NCT NCT01164098)
NCT ID: NCT01164098
Last Updated: 2018-09-20
Results Overview
Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
30 participants
Primary outcome timeframe
between post-transplant day 3 and day 30
Results posted on
2018-09-20
Participant Flow
Participant milestones
| Measure |
Rituximab
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rituximab to Prevent Recurrence of Proteinuria
Baseline characteristics by cohort
| Measure |
Rituximab
n=15 Participants
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
n=15 Participants
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: between post-transplant day 3 and day 30Population: Intent-to-Treat Analysis
Primary Outcome - Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30 will be compared between the two treatment arms using an intent-to-treat approach.
Outcome measures
| Measure |
Rituximab
n=15 Participants
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
n=15 Participants
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
|---|---|---|
|
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Days 3-30.
|
1.44 ratio
Standard Error 1.33
|
2.85 ratio
Standard Error 1.52
|
SECONDARY outcome
Timeframe: Post-Transplant Months 3-12Population: Intent-to-Treat Analysis
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12 will be compared between the two treatment arms using an intent-to-treat approach.
Outcome measures
| Measure |
Rituximab
n=15 Participants
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
n=15 Participants
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
|---|---|---|
|
Maximum of the Urine Protein/Creatinine Ratio Observed Between Post-Transplant Months 3-12
|
0.50 ratio
Standard Error 1.53
|
0.35 ratio
Standard Error 1.34
|
SECONDARY outcome
Timeframe: 12 months post-transplantPopulation: Intent-to-Treat Analysis
Renal function as measured by eGFR (estimated glomerular filtration rate) using the MDRD formula
Outcome measures
| Measure |
Rituximab
n=15 Participants
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
n=15 Participants
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
|---|---|---|
|
Renal Function as Measured by eGFR (Estimated Glomerular Filtration Rate)
|
57.1 ml/min/1.73 m^2
Standard Error 8.4
|
66.9 ml/min/1.73 m^2
Standard Error 6.6
|
Adverse Events
Rituximab
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
No Rituximab
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rituximab
n=15 participants at risk
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
n=15 participants at risk
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
6.7%
1/15 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Edema
|
6.7%
1/15 • Number of events 1 • 1 year
|
0.00%
0/15 • 1 year
|
Other adverse events
| Measure |
Rituximab
n=15 participants at risk
Participants will receive Rituximab post within 24 of Kidney Transplant
Rituximab: Induction therapy
|
No Rituximab
n=15 participants at risk
Participants will not receive Rituximab within 24 hours of Kidney Transplant
|
|---|---|---|
|
Investigations
Abnormal GGT
|
6.7%
1/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Blood and lymphatic system disorders
Acute Anemia
|
6.7%
1/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Immune system disorders
Acute T Cell Mediated Rejection
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Blood and lymphatic system disorders
Anemia
|
20.0%
3/15 • 1 year
|
20.0%
3/15 • 1 year
|
|
Hepatobiliary disorders
Ascites
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Nervous system disorders
Bilateral Carpal Tunnel
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Infections and infestations
BK Virus Replication
|
20.0%
3/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Renal and urinary disorders
Bladder Spasm
|
6.7%
1/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Infections and infestations
C-Diff Infection
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Eye disorders
Decrease Vision
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Dehydration
|
20.0%
3/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Investigations
Elevated Creatinine
|
20.0%
3/15 • 1 year
|
40.0%
6/15 • 1 year
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Blood and lymphatic system disorders
Evacuation of Subcapsular Hematoma
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Flu Like Syndrome
|
13.3%
2/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Metabolism and nutrition disorders
Fluid Overload
|
13.3%
2/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Upset
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
General disorders
Generalized Body Pain
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Generalized Edema
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Scrotal Edema
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Edema Extremeties
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Metabolism and nutrition disorders
Bilateral Lower Extremities Edema
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Legs Edema
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Renal and urinary disorders
Acute Tubular Necrosis
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
General disorders
Chest Pain
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Nervous system disorders
Headache
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Vascular disorders
Hematuria
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Vascular disorders
Hemorrhoids
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Blood and lymphatic system disorders
Hypercoagulability
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
20.0%
3/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Metabolism and nutrition disorders
Hyperphosphatemia
|
0.00%
0/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
6.7%
1/15 • 1 year
|
26.7%
4/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Hypocapnia
|
0.00%
0/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Metabolism and nutrition disorders
Hypokalemia
|
6.7%
1/15 • 1 year
|
20.0%
3/15 • 1 year
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
33.3%
5/15 • 1 year
|
40.0%
6/15 • 1 year
|
|
Metabolism and nutrition disorders
Hyponatremia
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.3%
2/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Blood and lymphatic system disorders
Leukopenia
|
13.3%
2/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
20.0%
3/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Gastrointestinal disorders
Mouth Ulcers
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Injury, poisoning and procedural complications
Motor Vehicle Accident
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Gastrointestinal disorders
Nausea and Vomiting
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Blood and lymphatic system disorders
Neutropenia
|
13.3%
2/15 • 1 year
|
53.3%
8/15 • 1 year
|
|
Injury, poisoning and procedural complications
Pain at Incision Site Radiating to Scrotal Area
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Reproductive system and breast disorders
Phimosis
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.7%
1/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Injury, poisoning and procedural complications
Post Surgical Pain
|
20.0%
3/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Renal and urinary disorders
Proteinuria
|
20.0%
3/15 • 1 year
|
26.7%
4/15 • 1 year
|
|
Infections and infestations
CMV Viremia
|
13.3%
2/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Vascular disorders
Steal Syndrome
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Swollen Right Lower Extremity
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Musculoskeletal and connective tissue disorders
Swollen Right Upper Extremity
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Injury, poisoning and procedural complications
T-Cell and Antibody Mediated Acute Rejection
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Renal and urinary disorders
Urinary Incontinence
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Renal and urinary disorders
Urinary Leak
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
6.7%
1/15 • 1 year
|
46.7%
7/15 • 1 year
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Infections and infestations
Vaginal Yeast Infection
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Infections and infestations
Viral Syndrome
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Gastrointestinal disorders
Vomiting and Diarrhea
|
6.7%
1/15 • 1 year
|
0.00%
0/15 • 1 year
|
|
Blood and lymphatic system disorders
Worsening Anemia
|
6.7%
1/15 • 1 year
|
13.3%
2/15 • 1 year
|
|
Vascular disorders
Worsening Hypertension
|
13.3%
2/15 • 1 year
|
26.7%
4/15 • 1 year
|
|
Endocrine disorders
Worsening Hyperglycemia
|
0.00%
0/15 • 1 year
|
6.7%
1/15 • 1 year
|
|
Injury, poisoning and procedural complications
Wound Infection
|
0.00%
0/15 • 1 year
|
13.3%
2/15 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place