IM103-133: Belatacept Therapy for the Failing Renal Allograft

• Sponsor: Andrew B Adams (Other)
• Overall Status: Completed
• CT.gov ID: NCT01921218
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 13
• Location: 1
• Arms: 2
• Duration (Months): 76.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

The purpose of this study is to test the safety and effectiveness of belatacept (Nulojix®) in preventing antibody formation in patients with chronic failing kidney transplants. This study is a randomized study of first-time kidney transplant patients who have worsening kidney function and biopsy proven grade 2 or 3 interstitial fibrosis/tubular atrophy (IF/TA). Patients must be eligible to get a second transplant. They must have completed or be actively undergoing evaluation for re-listing for a second transplant. Patients will be randomized to either convert to belatacept or continue on calcineurin inhibitor-based therapy.

Condition or Disease	Intervention/Treatment	Phase
Failing Renal Allograft	Drug: Belatacept; Drug: Calcineurin inhibitor therapy; Drug: Mycophenolate mofetil; Drug: prednisone	Phase 3

Detailed Description

The purpose of this study is to test the safety and effectiveness of the medicine belatacept (Nulojix®) in preventing antibodies from forming in people with a failing kidney transplant. Kidney transplant patients take immunosuppression medicines to prevent kidney rejection. When a kidney transplant begins to fail, the immunosuppression medicines are slowly weaned. Once dialysis is started, the immunosuppressant medicines are usually stopped. After immunosuppression is stopped, some people form antibodies. Antibodies are proteins that the immune system makes to protect against harmful foreign substances like bacteria, viruses, or foreign tissues, like a transplant. High levels of antibodies can make it harder to find a kidney donor for that person.

Participants will be randomized into one of the two treatment groups. One group will continue taking their current immunosuppression medicines. The people in the treatment group will be switched to belatacept (Nulojix®). Belatacept (Nulojix®) is an immunosuppression medicine that is approved by the U.S. Food and Drug Administration (the FDA) to prevent rejection in kidney transplant. Participants will stop taking calcineurin inhibitors (either cyclosporine or tacrolimus) or sirolimus but will keep taking other immunosuppression medicines like Cellcept (MMF) or azathioprine (Imuran) and prednisone. These medicines will be slowly weaned and will be stopped if the participant has to start dialysis. Participants will continue taking belatacept (Nulojix®), even while on dialysis.

The study team will test both groups to see how many people in each group develop antibodies.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Belatacept Therapy for the Failing Renal Allograft
• Study Start Date: Aug 1, 2013
• Actual Primary Completion Date: Dec 12, 2019
• Actual Study Completion Date: Dec 12, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Belatacept (Nulojix) IV	Drug: Belatacept; Belatacept, dosing 10mg/kg- day 0, 2 weeks, 1 month, 2 months, 3 months; subsequent doses 5mg/kg monthly through duration of trial or until retransplantation, whichever is first.; Other Names: Nulojix ; Drug: Mycophenolate mofetil; Continue current dose at enrollment. Upon initiation of dialysis, decrease dose by half, then discontinue 2 weeks later; Other Names: Cellcept ; Drug: prednisone; Begin steroid withdrawal one month after initiation of dialysis, with monthly reduction in dose by half, with plans to discontinue prednisone by 3 months after initiation of dialysis; Other Names: Deltasone
Active Comparator: Control Calcineurin inhibitor based therapy (cyclosporine or tacrolimus)	Drug: Calcineurin inhibitor therapy; Upon enrollment, wean calcineurin inhibitor (CNI) to target tacrolimus trough of 3-5 nanogram/milliliter (ng/ml)or equivalent cyclosporine trough. Upon initiation of hemodialysis, discontinue CNI therapy over 5 days.; Other Names: tacrolimus cyclosporine ; Drug: Mycophenolate mofetil; Continue current dose at enrollment. Upon initiation of dialysis, decrease dose by half, then discontinue 2 weeks later; Other Names: Cellcept ; Drug: prednisone; Begin steroid withdrawal one month after initiation of dialysis, with monthly reduction in dose by half, with plans to discontinue prednisone by 3 months after initiation of dialysis; Other Names: Deltasone

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Donor-specific Antibody Formation [Month 36]

   The number of participants in each group with donor-specific antibody formation at 36 months following randomization.

Secondary Outcome Measures

1. Glomerular Filtration Rate (GFR) [Baseline up to Month 24]

   The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years.

2. Time to Initiation of Dialysis [Up to Year 2]

   Time to dialysis is measured as the time of randomization to initiation of dialysis. Participants already requiring dialysis at the time of enrollment were excluded from this endpoint analysis.

3. Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies [Baseline up to Month 36]

   The presence of anti-HLA Class I and Class II alloantibodies is categorized as being negative (absent for both classes of alloantibodies), positive for Class I, positive for Class II, and positive for both Class I and Class II alloantibodies.

4. Number of Infectious Complications [Baseline up to Month 36]

   The number of infections complications occurring among study participants is presented here.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Signed written informed consent

• Kidney transplant recipient (human leukocyte antigen (HLA) non-identical donor) who now has impaired renal allograft function with:

• Estimated glomerular filtration rate (GFR) < 35 with a decline in GFR of > 10% in the 12 months prior to enrollment and must have biopsy proven grade II or III interstitial fibrosis/tubular atrophy (IF/TA) OR

• Estimated GFR persistently < 20 ml/min over the 6 month period prior to enrollment absent other causes for graft dysfunction, and deemed to have a failing allograft by the patient's transplant nephrologist

• On a maintenance immunosuppressive regimen that includes calcineurin inhibitor (CNI)(tacrolimus or cyclosporine) or sirolimus and at least

• MMF of a dose of at least 1 gm/day or comparable dose of azathioprine OR

• Prednisone at a dose of at least 5 mg/day

• Men and women, ages 18 to 70, inclusive

Exclusion Criteria:

• Women of childbearing potential (WOCBP) who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for up to 8 weeks after the last dose of study drug.

• Women who are pregnant or breastfeeding.

• Women with a positive pregnancy test.

• Sexually active fertile men not using effective birth control if their partners are WOCBP.

• Subjects who are Epstein-Barr Virus (EBV) seronegative.

• Subjects with any prior solid organ (e.g., heart, liver, pancreas) or cell (e.g., islet, bone marrow) transplant other than a renal allograft. Exception may be made for recipient of a simultaneous kidney-pancreas transplant who had previously experienced graft loss of the pancreas allograft due to thrombosis or rejection.

• Subjects with presence of donor specific antibody at the time of enrollment

• Subjects who have a recent history (within 1 yr) of biopsy proven acute rejection > Banff grade Ia

• Subjects who have a living donor identified for re-transplant within 3 months

• Subjects with a history of post-transplant lymphoproliferative disease (PTLD)

• Subjects at risk for tuberculosis (TB)

• Subjects with a history of cancer within the past 3 years, other than non-melanoma skin cancer(s)

• Subjects with a positive BK virus serum polymerase chain reaction (PCR) > 20,000 copies at the time of enrollment OR history of biopsy-proven BK nephropathy within the year prior to enrollment.

• Subjects with a mammogram that is suspicious for malignancy and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory, or other diagnostic evaluations

• Subjects who have difficult intravenous access or other reasons that would likely preclude the ability to receive long-term intravenous infusions

• Hypersensitivity to any medications that will be used in the protocol

• Subjects who have used any investigational drug within the 30 days prior to anticipated enrollment

• Subjects currently receiving belatacept as part of their maintenance immunosuppressive regimen

• Prisoners, or subjects who are involuntarily incarcerated.

• Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Andrew B Adams
• Bristol-Myers Squibb

Investigators

• Principal Investigator: Andrew B Adams, MD, PhD, Emory University

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 2, 2020

More Information

Publications

None provided.

• Responsible Party: Andrew B Adams, Assistant Professor of Surgery, Emory University
• ClinicalTrials.gov Identifier: NCT01921218
• Other Study ID Numbers: IRB00060470; IM103-133
• First Posted: Aug 13, 2013
• Last Update Posted: Jan 26, 2021
• Last Verified: Jan 1, 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Andrew B Adams, Assistant Professor of Surgery, Emory University: Kidney transplant
• Additional relevant MeSH terms: Cyclosporine; Mycophenolic Acid; Prednisone; Abatacept; Tacrolimus; Cyclosporins; Calcineurin Inhibitors

Study Results

Participant Flow

Recruitment Details	Participants were enrolled at Emory University Hospital and the Emory Clinic in Atlanta, Georgia. Enrollment began August 2013 and all follow up was complete by December 12, 2019.

Arm/Group Title	Belatacept Treatment Group	Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Period Title: Overall Study
STARTED	6	7
COMPLETED	3	3
NOT COMPLETED	3	4

Baseline Characteristics

Arm/Group Title	Belatacept Treatment Group	Control Group	Total
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression	Total of all reporting groups
Overall Participants	6	7	13
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 83.3%	7 100%	12 92.3%
>=65 years	1 16.7%	0 0%	1 7.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.12 (9.12)	45.69 (14.99)	51.31 (12.83)
Sex: Female, Male (Count of Participants)
Female	2 33.3%	2 28.6%	4 30.8%
Male	4 66.7%	5 71.4%	9 69.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	6 100%	7 100%	13 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Donor-specific Antibody Formation
Description	The number of participants in each group with donor-specific antibody formation at 36 months following randomization.
Time Frame	Month 36

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept Treatment Group	Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Measure Participants	4	4
Count of Participants [Participants]	3 50%	4 57.1%

2. Secondary Outcome

Title	Glomerular Filtration Rate (GFR)
Description	The glomerular filtration rate (GFR) assesses kidney function. GFR uses values for serum creatinine (SCr) measured in mg/dL, age in years, blood urea nitrogen (BUN) measures in mg/dL, and serum albumin (Alb) measured in g/dL. GFR is calculated as 170 x (SCr/0.95)^(-0.999) x (Age)^(-0.176) x (0.762 if the patient is female) x (1.180 if the patient is black) x (BUN)^(-0.170) x (Alb)^(0.318). A value of 90 or above is considered normal while values between 15 and 29 indicate severely decreased kidney function and values below 15 indicate kidney failure. The GFR in participants who do not require dialysis will be followed for two years.
Time Frame	Baseline up to Month 24

Outcome Measure Data

Analysis Population Description

Participants requiring dialysis, either at the time of enrollment or initiating dialysis during the study, are not included in this analysis.

Arm/Group Title	Belatacept Treatment Group	Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Measure Participants	4	2
Baseline	14.25 (7.80)	14.5 (0.71)
Month 1	14.25 (8.06)	11 (1.41)
Month 2	19.33 (4.93)	10.5 (4.95)
Month 3	16.33 (1.53)	16.5 (4.95)
Month 6	14.67 (1.15)	14.5 (6.36)
Month 9	14.67 (3.06)	13.5 (10.61)
Month 12	13.67 (2.89)	20 (0)
Month 18	7 (0)

3. Secondary Outcome

Title	Time to Initiation of Dialysis
Description	Time to dialysis is measured as the time of randomization to initiation of dialysis. Participants already requiring dialysis at the time of enrollment were excluded from this endpoint analysis.
Time Frame	Up to Year 2

Outcome Measure Data

Analysis Population Description

This analysis includes participants who initiated dialysis during the course of the study.

Arm/Group Title	Belatacept Treatment Group	Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Measure Participants	4	2
Mean (Standard Deviation) [months]	11.75 (7.46)	10.5 (2.12)

4. Secondary Outcome

Title	Number of Participants With Anti-human Leukocyte Antigen (HLA) Alloantibodies
Description	The presence of anti-HLA Class I and Class II alloantibodies is categorized as being negative (absent for both classes of alloantibodies), positive for Class I, positive for Class II, and positive for both Class I and Class II alloantibodies.
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

This analysis includes participants remaining in the study at the indicated study visit.

Arm/Group Title	Belatacept Treatment Group	Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Measure Participants	6	7
Baseline - Negative	6 100%	5 71.4%
Baseline - Positive Class I	0 0%	2 28.6%
Baseline - Positive Class II	0 0%	0 0%
Baseline - Positive Class I and II	0 0%	0 0%
Month 12 - Negative	4 66.7%	2 28.6%
Month 12 - Positive Class I	1 16.7%	4 57.1%
Month 12 - Positive Class II	0 0%	3 42.9%
Month 12 - Positive Class I and II	0 0%	3 42.9%
Month 24 - Negative	1 16.7%	1 14.3%
Month 24 - Positive Class I	0 0%	2 28.6%
Month 24 - Positive Class II	2 33.3%	1 14.3%
Month 24 - Positive Class I and II	0 0%	1 14.3%
Month 36 - Negative	1 16.7%	1 14.3%
Month 36 - Positive Class I	0 0%	2 28.6%
Month 36 - Positive Class II	2 33.3%	1 14.3%
Month 36 - Positive Class I and II	0 0%	1 14.3%

5. Secondary Outcome

Title	Number of Infectious Complications
Description	The number of infections complications occurring among study participants is presented here.
Time Frame	Baseline up to Month 36

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Belatacept Treatment Group	Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy	Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
Measure Participants	6	7
Number [complications]	12	18

Adverse Events

Time Frame	Data collection for adverse events began at the Baseline (Day 0) study visit and continued through the Month 36 Study Visit. Data collection for serious adverse events ended 8 weeks after the last administration of the study treatments (up to Month 38).
Adverse Event Reporting Description	Adverse events were graded by the physician investigator as follows: Mild (Grade 1): awareness of event but easily tolerated Moderate (Grade 2): discomfort enough to cause some interference with usual activity Severe (Grade 3): inability to carry out usual activity Very Severe (Grade 4): debilitating; significantly incapacitates subject despite symptomatic therapy.
Arm/Group Title	Belatacept Treatment Group		Control Group
Arm/Group Description	Participants with a failing kidney or failed kidney transplant receiving belatacept therapy		Participants with a failing kidney transplant continuing their current immunosuppression and once allograft failed discontinuing immunosuppression
All Cause Mortality
	Belatacept Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/6 (33.3%)		1/7 (14.3%)
Serious Adverse Events
	Belatacept Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/6 (66.7%)		5/7 (71.4%)
Blood and lymphatic system disorders
Deep vein thrombosis and pulmonary embolism	1/6 (16.7%)		0/7 (0%)
Cardiac disorders
Acute myocardial infarction	0/6 (0%)		1/7 (14.3%)
Atrial flutter	1/6 (16.7%)		0/7 (0%)
Gastrointestinal disorders
Gastrointestinal bleed	1/6 (16.7%)		0/7 (0%)
Diarrhea	0/6 (0%)		1/7 (14.3%)
General disorders
Chest pain	1/6 (16.7%)		0/7 (0%)
Acute rejection	0/6 (0%)		3/7 (42.9%)
Hypertensive crisis with seizure	0/6 (0%)		1/7 (14.3%)
Posterior Reversible Encephalopathy syndrome	0/6 (0%)		1/7 (14.3%)
Infections and infestations
Groin abscess	1/6 (16.7%)		0/7 (0%)
Cellulitis	0/6 (0%)		1/7 (14.3%)
Septic shock	0/6 (0%)		1/7 (14.3%)
Peritonitis with sepsis	0/6 (0%)		1/7 (14.3%)
Pneumonia related to H1N1 influenza culminating in death	1/6 (16.7%)		0/7 (0%)
Pneumonia	0/6 (0%)		1/7 (14.3%)
Infected permacath	0/6 (0%)		1/7 (14.3%)
Bacteremia	1/6 (16.7%)		0/7 (0%)
Escherichia coli urinary tract infection	1/6 (16.7%)		0/7 (0%)
Product Issues
Peritoneal dialysis catheter blockage or malfunction	1/6 (16.7%)		1/7 (14.3%)
Renal and urinary disorders
Initiation of hemodialysis	1/6 (16.7%)		0/7 (0%)
Increased creatinine	1/6 (16.7%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Pericardial effusion	0/6 (0%)		2/7 (28.6%)
Acute respiratory failure with hypoxia	0/6 (0%)		1/7 (14.3%)
Vascular disorders
Exacerbation of hypertension	2/6 (33.3%)		0/7 (0%)
Malfunctionig arteriovenous (AV) fistula with edema	1/6 (16.7%)		0/7 (0%)
Other (Not Including Serious) Adverse Events
	Belatacept Treatment Group		Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/6 (100%)		7/7 (100%)
Cardiac disorders
Chest pain, grade 3	1/6 (16.7%)		0/7 (0%)
Chest pain, grade 1	1/6 (16.7%)		4/7 (57.1%)
Atrial flutter, grade 1	1/6 (16.7%)		0/7 (0%)
Atrial fibrillation, grade 1	1/6 (16.7%)		2/7 (28.6%)
Aortic stenosis, grade 2	0/6 (0%)		1/7 (14.3%)
Ear and labyrinth disorders
Otitis media, grade 2	0/6 (0%)		5/7 (71.4%)
Eustacian tube dysfunction, grade 2	0/6 (0%)		1/7 (14.3%)
Right clogged ear, grade 1	1/6 (16.7%)		0/7 (0%)
Endocrine disorders
Hyperparathyroidism, grade 2	1/6 (16.7%)		0/7 (0%)
Hypoglycemia, grade 3	1/6 (16.7%)		0/7 (0%)
Eye disorders
Keratitis dendritic herpes, grade 2	0/6 (0%)		1/7 (14.3%)
Scleral redness, grade 1	1/6 (16.7%)		0/7 (0%)
Gastrointestinal disorders
Abdominal cramps, grade 1	1/6 (16.7%)		0/7 (0%)
Diarrhea, grade 1	3/6 (50%)		4/7 (57.1%)
Diarrhea, grade 2	3/6 (50%)		2/7 (28.6%)
Abdominal pain, grade 2	1/6 (16.7%)		0/7 (0%)
Colitis, grade 3	0/6 (0%)		1/7 (14.3%)
Vomiting, grade 2	1/6 (16.7%)		1/7 (14.3%)
Vomiting, grade 3	1/6 (16.7%)		0/7 (0%)
Diarrhea, grade 3	1/6 (16.7%)		0/7 (0%)
Indigestion, grade 1	1/6 (16.7%)		0/7 (0%)
Sigmoid diverticulosis, grade 1	1/6 (16.7%)		0/7 (0%)
Internal hemorrhoids, grade 1	0/6 (0%)		1/7 (14.3%)
General disorders
Fatigue, grade 1	1/6 (16.7%)		0/7 (0%)
Fatigue, grade 2	3/6 (50%)		0/7 (0%)
Nausea, grade 1	2/6 (33.3%)		2/7 (28.6%)
Bilateral restless legs, grade 1	2/6 (33.3%)		0/7 (0%)
Forgetfulness, grade 1	2/6 (33.3%)		0/7 (0%)
Nervousness, grade 1	2/6 (33.3%)		0/7 (0%)
Lesion on upper palate, grade 1	1/6 (16.7%)		0/7 (0%)
Hypocalcemia, grade 2	1/6 (16.7%)		0/7 (0%)
Sycopal episode, grade 3	0/6 (0%)		1/7 (14.3%)
Graft tenderness, grade 1	0/6 (0%)		2/7 (28.6%)
Posterior reversible encephalopathy, grade 3	0/6 (0%)		1/7 (14.3%)
Exacerbation of baseline anemia, grade 2	0/6 (0%)		1/7 (14.3%)
Pericardial effusion, grade 3	0/6 (0%)		1/7 (14.3%)
Acute pharyngitis, grade 2	0/6 (0%)		2/7 (28.6%)
Shin injury, grade 2	0/6 (0%)		1/7 (14.3%)
Cold sensitivity, grade 1	0/6 (0%)		1/7 (14.3%)
Nausea, grade 3	1/6 (16.7%)		0/7 (0%)
Lower extremity edema, grade 1	4/6 (66.7%)		0/7 (0%)
Hyperkalemia, grade 2	1/6 (16.7%)		0/7 (0%)
Hyperphosphatemia, grade 2	1/6 (16.7%)		0/7 (0%)
Hypotension, grade 2	1/6 (16.7%)		0/7 (0%)
Headache, grade 1	1/6 (16.7%)		0/7 (0%)
Hot flashes, grade 1	1/6 (16.7%)		0/7 (0%)
Asymmetry in right breast, grade 1	1/6 (16.7%)		0/7 (0%)
Intermittent bilateral foot swelling, grade 1	1/6 (16.7%)		0/7 (0%)
Hypokalemia, grade 2	1/6 (16.7%)		0/7 (0%)
Dry cough, grade 1	1/6 (16.7%)		0/7 (0%)
Perihepatic ascites, grade 1	1/6 (16.7%)		0/7 (0%)
Weight loss, grade 2	1/6 (16.7%)		0/7 (0%)
Bilateral hip edema, grade 1	1/6 (16.7%)		0/7 (0%)
Exacerbation of anemia, grade 1	1/6 (16.7%)		0/7 (0%)
Shaking, grade 1	1/6 (16.7%)		0/7 (0%)
Peritoneal catheter removal, grade 1	1/6 (16.7%)		0/7 (0%)
Exacerbation of insomnia, grade 2	1/6 (16.7%)		0/7 (0%)
Weight gain, grade 2	1/6 (16.7%)		0/7 (0%)
Syncopal episode, grade 3	0/6 (0%)		1/7 (14.3%)
Fever, grade 2	0/6 (0%)		1/7 (14.3%)
Hypervolemia, grade 1	0/6 (0%)		1/7 (14.3%)
Enlarged axillary lymph node, grade 1	0/6 (0%)		1/7 (14.3%)
Hypokalemia, grade 1	0/6 (0%)		2/7 (28.6%)
Dizziness, grade 1	0/6 (0%)		1/7 (14.3%)
Diaphoresis, grade 1	0/6 (0%)		1/7 (14.3%)
Lower extremity swelling, grade 1	0/6 (0%)		1/7 (14.3%)
Infections and infestations
Peritonitis, grade 2	3/6 (50%)		4/7 (57.1%)
Upper respiratory infection, grade 2	2/6 (33.3%)		0/7 (0%)
Upper respiratory infection, grade 1	1/6 (16.7%)		0/7 (0%)
Urinary tract infection with bacteremia, grade 3	1/6 (16.7%)		0/7 (0%)
Peritoneal dialysis site infection, grade 2	1/6 (16.7%)		0/7 (0%)
Influenza A and B, grade 2	1/6 (16.7%)		0/7 (0%)
Pneumonia, grade 2	1/6 (16.7%)		0/7 (0%)
Shingles, grade 1	0/6 (0%)		2/7 (28.6%)
Pneumonia, grade 3	0/6 (0%)		1/7 (14.3%)
Cellulitis, grade 2	0/6 (0%)		1/7 (14.3%)
Sinusitis, grade 2	0/6 (0%)		1/7 (14.3%)
Viral syndrome, grade 2	0/6 (0%)		1/7 (14.3%)
Febrile illness, grade 1	0/6 (0%)		2/7 (28.6%)
Urinary tract infection, grade 2	1/6 (16.7%)		0/7 (0%)
Peritonitis, grade 1	0/6 (0%)		1/7 (14.3%)
Serratia bacteremia, grade 2	0/6 (0%)		1/7 (14.3%)
Injury, poisoning and procedural complications
Fractured toes due to motor vehicle accident, grade 2	1/6 (16.7%)		0/7 (0%)
Burst bursa sac after fall, grade 2	1/6 (16.7%)		0/7 (0%)
Metatarsal fracture, grade 2	0/6 (0%)		1/7 (14.3%)
Metabolism and nutrition disorders
Hypoglycemia, grade 2	2/6 (33.3%)		0/7 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia, grade 2	1/6 (16.7%)		0/7 (0%)
Arthralgia, grade 1	2/6 (33.3%)		0/7 (0%)
Left leg cramps, grade 2	1/6 (16.7%)		0/7 (0%)
Bilateral feet cramps, grade 1	1/6 (16.7%)		0/7 (0%)
Disc protrusion, grade 2	1/6 (16.7%)		0/7 (0%)
Facet joint hypertrophy, grade 2	1/6 (16.7%)		0/7 (0%)
Tendonitis bilateral ankles, grade 1	2/6 (33.3%)		0/7 (0%)
Knee meniscus tear, grade 2	1/6 (16.7%)		0/7 (0%)
Osteoarthritis in knee, grade 2	1/6 (16.7%)		0/7 (0%)
Leg pain possibly due to sciatica, grade 2	2/6 (33.3%)		0/7 (0%)
Exacerbation of gout, grades 2 and 3	2/6 (33.3%)		0/7 (0%)
Intermittent bone pain, grade 1	1/6 (16.7%)		0/7 (0%)
Intermittent jaw pain, grade 1	1/6 (16.7%)		0/7 (0%)
Scapular pain, grade 1	1/6 (16.7%)		0/7 (0%)
Intermittent hand cramping, grade 1	1/6 (16.7%)		0/7 (0%)
Muscle aches, grade 2	1/6 (16.7%)		0/7 (0%)
Lower extremity weakness, grade 2	1/6 (16.7%)		0/7 (0%)
Lower spine pain, grade 2	1/6 (16.7%)		0/7 (0%)
Shoulder pain, grade 1	2/6 (33.3%)		0/7 (0%)
Foot pain, grade 1	1/6 (16.7%)		0/7 (0%)
Weakness, grade 1	1/6 (16.7%)		0/7 (0%)
Joint pain, grade 1	0/6 (0%)		1/7 (14.3%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma, grades 1 and 2	1/6 (16.7%)		0/7 (0%)
Multiple non-malignant skin lesions, grade 1	1/6 (16.7%)		0/7 (0%)
Product Issues
Peritoneal dialysis catheter malfunction, grade 3	0/6 (0%)		1/7 (14.3%)
Chest wall pain at site of dialysis catheter, grade 1	1/6 (16.7%)		0/7 (0%)
Psychiatric disorders
Anxiety, grade 1	1/6 (16.7%)		0/7 (0%)
Altered mental status, grade 3	1/6 (16.7%)		0/7 (0%)
Renal and urinary disorders
Hematuria, grade 1	0/6 (0%)		2/7 (28.6%)
Rise in creatinine, grade 2	0/6 (0%)		1/7 (14.3%)
Pyelonephritis, grade 1	0/6 (0%)		1/7 (14.3%)
Reproductive system and breast disorders
Benign right ovarian cysts, grade 1	1/6 (16.7%)		0/7 (0%)
Respiratory, thoracic and mediastinal disorders
Pulmonary edema, grade 1	1/6 (16.7%)		0/7 (0%)
Coughing and wheezing, grade 2	2/6 (33.3%)		0/7 (0%)
Shortness of breath, grade 1	1/6 (16.7%)		0/7 (0%)
Chronic pulmonary embolus, grade 2	1/6 (16.7%)		0/7 (0%)
Sinus congestion, grade 1	1/6 (16.7%)		0/7 (0%)
Skin and subcutaneous tissue disorders
Pruritus, grade 2	2/6 (33.3%)		0/7 (0%)
Hives bilateral lower leg, grade 1	1/6 (16.7%)		0/7 (0%)
Generalized urticaria, grade 1	1/6 (16.7%)		0/7 (0%)
Lip sore, grade 1	1/6 (16.7%)		0/7 (0%)
Pressure ulcers on sacrum and coccyx, grade 3	1/6 (16.7%)		0/7 (0%)
Surgical and medical procedures
Knee replacement, grade 2	0/6 (0%)		1/7 (14.3%)
Knee drainage, grade 1	0/6 (0%)		1/7 (14.3%)
Lesions removed from arm, grade 2	1/6 (16.7%)		0/7 (0%)
Vascular disorders
Hypertension, grade 3	1/6 (16.7%)		1/7 (14.3%)
Hypotension, grade 1	0/6 (0%)		1/7 (14.3%)
Hypertensive crisis, grade 2	0/6 (0%)		2/7 (28.6%)
Hypertension exacerbation, grade 1	1/6 (16.7%)		0/7 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.