Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer (Industry)

Overall Status

Completed

CT.gov ID

NCT00038948

Collaborator

(none)

830

Enrollment

Arms

Duration (Months)

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the effect of conversion from calcineurin inhibitor to sirolimus based therapy on renal function.

Condition or Disease	Intervention/Treatment	Phase
Renal Transplantation	Drug: Sirolimus Drug: tacrolimus Drug: Cyclosporine A	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

830 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Open-label, Comparative Evaluation of Conversion From Calcineurin Inhibitors to Sirolimus Versus Continued Use of Calcineurin Inhibitors in Renal Allograft Recipients

Study Start Date :

Jan 1, 2002

Actual Primary Completion Date :

May 1, 2008

Actual Study Completion Date :

May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: A Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression	Drug: Sirolimus Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled Drug: tacrolimus Drug: Cyclosporine A
Active Comparator: B Continued calcineurin inhibitor therapy	Drug: Sirolimus Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled Drug: tacrolimus Drug: Cyclosporine A

Arm

Intervention/Treatment

Active Comparator: A

Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression

Drug: Sirolimus

Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled

Drug: tacrolimus

Drug: Cyclosporine A

Active Comparator: B

Continued calcineurin inhibitor therapy

Drug: Sirolimus

Sirolimus, Cyclosporine A & Tacrolimus are concentration controlled

Drug: tacrolimus

Drug: Cyclosporine A

Outcome Measures

Primary Outcome Measures

Nankivell Glomerular Filtration Rate (GFR) [52 weeks]
Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.

Secondary Outcome Measures

First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death. [52 and 104 weeks]
Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).

Eligibility Criteria

Criteria

Ages Eligible for Study:

13 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age greater than or equal to 13 years.
Receiving CsA or tacrolimus from the time of transplantation or within 2 weeks thereafter
Patients with a functioning allograft and a Nankivell GFR greater than or equal to 20 mL/min, within 2 weeks before randomization

Exclusion Criteria:

Biopsy-confirmed acute rejection within 12 weeks before randomization, that was determined to require antirejection treatment
Patients in whom kidney-pancreas or other multiple organ transplants have been performed

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Wyeth is now a wholly owned subsidiary of Pfizer

Investigators

Study Director: Medical Monitor, MD, Wyeth is now a wholly owned subsidiary of Pfizer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00038948

Other Study ID Numbers:

0468H1-316

First Posted:

Jun 7, 2002

Last Update Posted:

May 14, 2010

Last Verified:

Apr 1, 2010

Keywords provided by , ,

Renal

Allograft

Recipients

Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details	Patients were recruited worldwide from January 2002 to September 2003.
Pre-assignment Detail	Patients were screened for two weeks.

Arm/Group Title	SRL Conversion in Stable Renal Transplant Recipients	CNI Continuation in Stable Renal Transplant Recipients
Arm/Group Description	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.	Continued calcineurin inhibitor immunosuppression therapy
Period Title: Overall Study
STARTED	555	275
COMPLETED	386	198
NOT COMPLETED	169	77

Baseline Characteristics

Arm/Group Title	SRL Conversion in Stable Renal Transplant Recipients	CNI Continuation in Stable Renal Transplant Recipients	Total
Arm/Group Description	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.	Continued calcineurin inhibitor immunosuppression therapy	Total of all reporting groups
Overall Participants	555	275	830
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	45.00	43.50	44.50
Sex: Female, Male (Count of Participants)
Female	170 30.6%	81 29.5%	251.0 30.2%
Male	385 69.4%	194 70.5%	579.0 69.8%

Outcome Measures

1. Primary Outcome

Title	Nankivell Glomerular Filtration Rate (GFR)
Description	Nankivell GFR: patients with baseline GFR of 20.0 to 40.0 mL/min and patients with baseline GFR of greater than 40.0 mL/min. GFR is an index of kidney function. A higher value means better kidney function.
Time Frame	52 weeks

Outcome Measure Data

Analysis Population Description
Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.

Arm/Group Title	SRL Conversion Strata 20.0-40.0 mL/Min	CNI Continuation Strata 20.0-40.0 mL/Min	SRL Conversion Strata >40.0 mL/Min	CNI Continuation Strata >40.0 mL/Min
Arm/Group Description	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients	Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.	Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
Measure Participants	58	29	496	245
Mean (Standard Error) [mL/min]	24.56 (2.42)	27.24 (3.71)	59.04 (0.89)	57.73 (1.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SRL Conversion Strata 20.0-40.0 mL/Min, CNI Continuation Strata 20.0-40.0 mL/Min
	Comments	Baseline GFR of 20.0 to 40.0 mL/min
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.575
	Comments	Analysis of covariance p-value
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Weighted difference
	Estimated Value	-2.68
	Confidence Interval	() 95% -12.27 to 6.91
	Parameter Dispersion	Type: Value:
	Estimation Comments	Data was adjusted for baseline and center.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SRL Conversion Strata >40.0 mL/Min, CNI Continuation Strata >40.0 mL/Min
	Comments	Baseline GFR of >40.0 mL/min
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.278
	Comments	Analysis of covariance p-value
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Weighted difference
	Estimated Value	1.31
	Confidence Interval	() 95% -1.06 to 3.69
	Parameter Dispersion	Type: Value:
	Estimation Comments	Data was adjusted for baseline and center.

2. Secondary Outcome

Title	First Occurrence of Biopsy-confirmed Acute Rejection, Graft Loss, or Death.
Description	Number of patients who experienced for the first time either biopsy-confirmed acute rejection, graft loss, or death by weeks 52 and 104. Assessed by individual endpoint and as composite endpoint (all combined).
Time Frame	52 and 104 weeks

Outcome Measure Data

Analysis Population Description
Patients were stratified by GFR at baseline. GFR 20-40 mL/min and GFR >40 mL/min.

Arm/Group Title	SRL Conversion Strata 20.0-40.0 mL/Min	CNI Continuation Strata 20.0-40.0 mL/Min	SRL Conversion Strata >40.0 mL/Min	CNI Continuation Strata >40.0 mL/Min
Arm/Group Description	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression	Continued calcineurin inhibitor therapy	Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression	Continued calcineurin inhibitor therapy
Measure Participants	58	29	497	246
52 weeks - Acute rejection	4	0	8	3
52 weeks - Graft loss	7	3	3	3
52 weeks - Death	3	0	6	1
52 weeks - Missing	0	0	5	1
104 weeks - Acute rejection	5	1	27	9
104 weeks - Graft loss	12	9	12	8
104 weeks - Death	7	0	13	3
104 weeks - Missing	0	2	13	8

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SRL Conversion Strata 20.0-40.0 mL/Min, CNI Continuation Strata 20.0-40.0 mL/Min, SRL Conversion Strata >40.0 mL/Min, CNI Continuation Strata >40.0 mL/Min
	Comments	52 weeks statistical analysis across strata
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.135
	Comments	Tests the equality of rates between treatments across strata at 52 weeks.
	Method	Cochran-Mantel-Haenszel
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	SRL Conversion Strata 20.0-40.0 mL/Min, CNI Continuation Strata 20.0-40.0 mL/Min, SRL Conversion Strata >40.0 mL/Min, CNI Continuation Strata >40.0 mL/Min
	Comments	104 weeks statistical analysis across strata
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.559
	Comments	Tests the equality of rates between treatments across strata at 104 weeks.
	Method	Cochran-Mantel-Haenszel
	Comments

Adverse Events

	SRL Conversion in Stable Renal Transplant Recipients		CNI Continuation in Stable Renal Transplant Recipients
Time Frame
Adverse Event Reporting Description

Arm/Group Title	SRL Conversion in Stable Renal Transplant Recipients		CNI Continuation in Stable Renal Transplant Recipients
Arm/Group Description	Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.		Continued calcineurin inhibitor immunosuppression therapy
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SRL Conversion in Stable Renal Transplant Recipients		CNI Continuation in Stable Renal Transplant Recipients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	81/551 (14.7%)		45/273 (16.5%)
Blood and lymphatic system disorders
Anemia	21/551 (3.8%)		3/273 (1.1%)
Hemolytic anemia	1/551 (0.2%)		0/273 (0%)
International normalized ratio increased	1/551 (0.2%)		0/273 (0%)
Iron deficiency anemia	1/551 (0.2%)		0/273 (0%)
Luekocytosis	1/551 (0.2%)		0/273 (0%)
Luekopenia	4/551 (0.7%)		0/273 (0%)
Lymphoma like reaction	4/551 (0.7%)		0/273 (0%)
Neutropenia	1/551 (0.2%)		0/273 (0%)
Pancytopenia	2/551 (0.4%)		0/273 (0%)
Thrombocytopenia	3/551 (0.5%)		0/273 (0%)
Thrombotic thrombocytopenic purpura	1/551 (0.2%)		0/273 (0%)
Cardiac disorders
Aneurysm	2/551 (0.4%)		3/273 (1.1%)
Angina pectoris	2/551 (0.4%)		1/273 (0.4%)
Aortic stenosis	1/551 (0.2%)		0/273 (0%)
Arrhythmia	1/551 (0.2%)		0/273 (0%)
Arteriosclerosis	0/551 (0%)		1/273 (0.4%)
Atrial fibrillation	2/551 (0.4%)		3/273 (1.1%)
Atrial flutter	0/551 (0%)		1/273 (0.4%)
Bradycardia	1/551 (0.2%)		0/273 (0%)
Cardiac tamponade	1/551 (0.2%)		0/273 (0%)
Cardiomyopathy	3/551 (0.5%)		0/273 (0%)
Cardiovascular disorder	2/551 (0.4%)		2/273 (0.7%)
Congestive heart failure	6/551 (1.1%)		2/273 (0.7%)
Coronary artery disorder	3/551 (0.5%)		1/273 (0.4%)
Cyanosis	1/551 (0.2%)		0/273 (0%)
Endocarditis	1/551 (0.2%)		0/273 (0%)
Heart arrest	6/551 (1.1%)		2/273 (0.7%)
Heart failure	5/551 (0.9%)		1/273 (0.4%)
Hypertension	13/551 (2.4%)		4/273 (1.5%)
Hypotension	1/551 (0.2%)		3/273 (1.1%)
Infarct	0/551 (0%)		1/273 (0.4%)
Migraine	1/551 (0.2%)		0/273 (0%)
Myocardial infarct	2/551 (0.4%)		0/273 (0%)
Pericardial effusion	2/551 (0.4%)		0/273 (0%)
Pericarditis	0/551 (0%)		2/273 (0.7%)
Pulmonary embolus	3/551 (0.5%)		1/273 (0.4%)
Shock	4/551 (0.7%)		0/273 (0%)
Syncope	1/551 (0.2%)		0/273 (0%)
Valvular heart disease	1/551 (0.2%)		0/273 (0%)
Ear and labyrinth disorders
Otitis externa	1/551 (0.2%)		0/273 (0%)
Otitis media	3/551 (0.5%)		0/273 (0%)
Eye disorders
Cataract specified	1/551 (0.2%)		0/273 (0%)
Parosmia	1/551 (0.2%)		0/273 (0%)
Gastrointestinal disorders
Anorexia	1/551 (0.2%)		0/273 (0%)
Aphthous stomatitis	3/551 (0.5%)		0/273 (0%)
Bloody diarrhea	1/551 (0.2%)		0/273 (0%)
Cholelithiasis	3/551 (0.5%)		1/273 (0.4%)
Colitis	8/551 (1.5%)		1/273 (0.4%)
Constipation	0/551 (0%)		1/273 (0.4%)
Diarrhea	36/551 (6.5%)		3/273 (1.1%)
Duodenitis	0/551 (0%)		1/273 (0.4%)
Dyspepsia	1/551 (0.2%)		0/273 (0%)
Dysphagia	1/551 (0.2%)		0/273 (0%)
Enterocolitits	1/551 (0.2%)		0/273 (0%)
Esophageal hemorrhage	1/551 (0.2%)		0/273 (0%)
Esophagitis	2/551 (0.4%)		1/273 (0.4%)
Flatulence	0/551 (0%)		1/273 (0.4%)
Gastritis	5/551 (0.9%)		0/273 (0%)
Gastroenteritis	28/551 (5.1%)		4/273 (1.5%)
Gastrointestinal disorder general	3/551 (0.5%)		2/273 (0.7%)
Gastrointestinal hemorrhage	3/551 (0.5%)		1/273 (0.4%)
Hematemesis	1/551 (0.2%)		0/273 (0%)
Ileus	2/551 (0.4%)		0/273 (0%)
Intestinal nercosis	1/551 (0.2%)		0/273 (0%)
Intestinal obstruction	2/551 (0.4%)		1/273 (0.4%)
Intestinal perforation	1/551 (0.2%)		0/273 (0%)
Intestinal ulcer	1/551 (0.2%)		0/273 (0%)
Melena	1/551 (0.2%)		0/273 (0%)
Mouth ulcerations	2/551 (0.4%)		0/273 (0%)
Nausea	9/551 (1.6%)		1/273 (0.4%)
Nausea and vomiting	0/551 (0%)		2/273 (0.7%)
Oral moniliasis	1/551 (0.2%)		0/273 (0%)
Rectal disorder	2/551 (0.4%)		0/273 (0%)
Rectal hemorrhage	2/551 (0.4%)		1/273 (0.4%)
Stomatitis	1/551 (0.2%)		0/273 (0%)
Ulcerative colitis	1/551 (0.2%)		0/273 (0%)
Ulcerative proctitis	1/551 (0.2%)		0/273 (0%)
Vomiting	9/551 (1.6%)		3/273 (1.1%)
Cholecystitis	1/551 (0.2%)		0/273 (0%)
General disorders
Abdominal pain	19/551 (3.4%)		5/273 (1.8%)
Abdominal syndrome acute	3/551 (0.5%)		2/273 (0.7%)
Abscess	7/551 (1.3%)		2/273 (0.7%)
Accidental injury	14/551 (2.5%)		3/273 (1.1%)
Accidental overdose	2/551 (0.4%)		1/273 (0.4%)
Allergic reaction	1/551 (0.2%)		0/273 (0%)
Ascites	1/551 (0.2%)		0/273 (0%)
Asthenia	1/551 (0.2%)		0/273 (0%)
Back pain	2/551 (0.4%)		2/273 (0.7%)
Carcinoma	0/551 (0%)		1/273 (0.4%)
Cellulitis	10/551 (1.8%)		3/273 (1.1%)
Chest pain	8/551 (1.5%)		2/273 (0.7%)
Chills	5/551 (0.9%)		0/273 (0%)
Chills and fever	1/551 (0.2%)		0/273 (0%)
Cyst	0/551 (0%)		1/273 (0.4%)
Drug level increased	1/551 (0.2%)		0/273 (0%)
Face edema	2/551 (0.4%)		0/273 (0%)
Fever	43/551 (7.8%)		10/273 (3.7%)
Flu syndrome	4/551 (0.7%)		0/273 (0%)
Gangrene	2/551 (0.4%)		0/273 (0%)
Generalized edema	3/551 (0.5%)		0/273 (0%)
Granuloma	1/551 (0.2%)		0/273 (0%)
Headache	1/551 (0.2%)		0/273 (0%)
Hernia	5/551 (0.9%)		2/273 (0.7%)
Infection	40/551 (7.3%)		8/273 (2.9%)
Lab test abnormal	3/551 (0.5%)		0/273 (0%)
Lymphocele	1/551 (0.2%)		0/273 (0%)
Moniliasis	1/551 (0.2%)		0/273 (0%)
Neck pain	0/551 (0%)		1/273 (0.4%)
Overdose	4/551 (0.7%)		1/273 (0.4%)
Pain	2/551 (0.4%)		1/273 (0.4%)
Pelvic pain	0/551 (0%)		1/273 (0.4%)
Peritonitis	2/551 (0.4%)		1/273 (0.4%)
Sepsis	17/551 (3.1%)		5/273 (1.8%)
Septic shock	3/551 (0.5%)		1/273 (0.4%)
Suicide attempt	1/551 (0.2%)		0/273 (0%)
Transplant rejection	18/551 (3.3%)		4/273 (1.5%)
Device malfunction	3/551 (0.5%)		0/273 (0%)
Other etiology unknown	0/551 (0%)		2/273 (0.7%)
Hepatobiliary disorders
Hepatic failure	1/551 (0.2%)		0/273 (0%)
Hepatitis	1/551 (0.2%)		0/273 (0%)
Hepatosplenomegaly	0/551 (0%)		1/273 (0.4%)
Liver damage	1/551 (0.2%)		0/273 (0%)
Liver function tests abnormal	8/551 (1.5%)		0/273 (0%)
Liver tenderness	1/551 (0.2%)		0/273 (0%)
Pancreatitis	2/551 (0.4%)		1/273 (0.4%)
Pancreas disorder	1/551 (0.2%)		1/273 (0.4%)
Injury, poisoning and procedural complications
Local reaction to procedure	16/551 (2.9%)		7/273 (2.6%)
Metabolism and nutrition disorders
Diabetes mellitus	4/551 (0.7%)		3/273 (1.1%)
Parathyroid disorder	4/551 (0.7%)		3/273 (1.1%)
Blood uria nitrogren increased	9/551 (1.6%)		3/273 (1.1%)
Acidosis	2/551 (0.4%)		0/273 (0%)
Amyloidosis	1/551 (0.2%)		0/273 (0%)
Calcium disorder	1/551 (0.2%)		0/273 (0%)
Creatinine increased	36/551 (6.5%)		9/273 (3.3%)
Dehydration	14/551 (2.5%)		3/273 (1.1%)
Diabetic ketoacidosis	2/551 (0.4%)		2/273 (0.7%)
Edema	3/551 (0.5%)		0/273 (0%)
Electrolyte abnormality	1/551 (0.2%)		0/273 (0%)
Gout	1/551 (0.2%)		0/273 (0%)
Healing abnormal	5/551 (0.9%)		3/273 (1.1%)
Hypercalcemia	0/551 (0%)		2/273 (0.7%)
Hypercholesteremia	1/551 (0.2%)		0/273 (0%)
Hyperglycemia	2/551 (0.4%)		2/273 (0.7%)
Hyperkalemia	1/551 (0.2%)		0/273 (0%)
Hyperlipemia	3/551 (0.5%)		0/273 (0%)
Hypoglycemia	1/551 (0.2%)		0/273 (0%)
Hypokalemia	1/551 (0.2%)		0/273 (0%)
Hyponatremia	0/551 (0%)		2/273 (0.7%)
Peripheral edema	9/551 (1.6%)		2/273 (0.7%)
Respiratory acidosis	1/551 (0.2%)		0/273 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	4/551 (0.7%)		1/273 (0.4%)
Arthrosis	1/551 (0.2%)		1/273 (0.4%)
Bone necrosis	6/551 (1.1%)		0/273 (0%)
Bone pain	1/551 (0.2%)		0/273 (0%)
Fasciitis	1/551 (0.2%)		0/273 (0%)
Joint disorder	1/551 (0.2%)		1/273 (0.4%)
Myasthenia	0/551 (0%)		1/273 (0.4%)
Myopathy	0/551 (0%)		1/273 (0.4%)
Necrotising faciitis	1/551 (0.2%)		0/273 (0%)
Osteoporosis	0/551 (0%)		1/273 (0.4%)
Rhabdomyolysis	2/551 (0.4%)		0/273 (0%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm	0/551 (0%)		1/273 (0.4%)
Carcinoma of the mouth	1/551 (0.2%)		0/273 (0%)
Gastrointestinal carcinoma	1/551 (0.2%)		1/273 (0.4%)
Aplastic anemia	1/551 (0.2%)		0/273 (0%)
Chronic leukemia	1/551 (0.2%)		0/273 (0%)
Lymphadenopathy	0/551 (0%)		1/273 (0.4%)
Carcinoma of the lung	0/551 (0%)		1/273 (0.4%)
Skin carcinoma	7/551 (1.3%)		15/273 (5.5%)
Skin granuloma	1/551 (0.2%)		0/273 (0%)
Skin melanoma	0/551 (0%)		2/273 (0.7%)
Breast carcinoma	0/551 (0%)		1/273 (0.4%)
Cervix carcinoma	0/551 (0%)		1/273 (0.4%)
Endometrial carcinoma	0/551 (0%)		1/273 (0.4%)
Ovarian cyst	4/551 (0.7%)		0/273 (0%)
Prostatic carcinoma	3/551 (0.5%)		2/273 (0.7%)
Nervous system disorders
Central nervous system anomaly	0/551 (0%)		1/273 (0.4%)
Agitation	1/551 (0.2%)		0/273 (0%)
Confusion	2/551 (0.4%)		1/273 (0.4%)
Convulsion	1/551 (0.2%)		2/273 (0.7%)
Depression	2/551 (0.4%)		0/273 (0%)
Encephalopathy	1/551 (0.2%)		0/273 (0%)
Hostility	1/551 (0.2%)		0/273 (0%)
Meningitis	2/551 (0.4%)		0/273 (0%)
Nerve root compression	0/551 (0%)		1/273 (0.4%)
Neuralgia	2/551 (0.4%)		0/273 (0%)
Neuropathy	2/551 (0.4%)		0/273 (0%)
Somnolence	1/551 (0.2%)		0/273 (0%)
Vocal chord paralysis	1/551 (0.2%)		0/273 (0%)
Renal and urinary disorders
Acute kidney failure	11/551 (2%)		4/273 (1.5%)
Albuminuria	8/551 (1.5%)		1/273 (0.4%)
Anuria	0/551 (0%)		1/273 (0.4%)
Dysuria	1/551 (0.2%)		0/273 (0%)
Glomerulitis	5/551 (0.9%)		2/273 (0.7%)
Hematuria	3/551 (0.5%)		0/273 (0%)
Hydronephrosis	6/551 (1.1%)		0/273 (0%)
Hydroureter	0/551 (0%)		1/273 (0.4%)
Kidney calculus	1/551 (0.2%)		0/273 (0%)
Kidney failure	13/551 (2.4%)		9/273 (3.3%)
Kidney function abnormal	29/551 (5.3%)		18/273 (6.6%)
Kidney tubular disorder	1/551 (0.2%)		0/273 (0%)
Kidney tubular necrosis	0/551 (0%)		1/273 (0.4%)
Metrorrhagia	3/551 (0.5%)		1/273 (0.4%)
Nephritis	3/551 (0.5%)		1/273 (0.4%)
Nephrosclerosis	3/551 (0.5%)		0/273 (0%)
Nephrosis	9/551 (1.6%)		0/273 (0%)
Oliguria	2/551 (0.4%)		0/273 (0%)
Polycystic kidney	1/551 (0.2%)		0/273 (0%)
Pyelonephritis	12/551 (2.2%)		4/273 (1.5%)
Scrotal edema	1/551 (0.2%)		0/273 (0%)
Toxic nephropathy	1/551 (0.2%)		0/273 (0%)
Uremia	4/551 (0.7%)		0/273 (0%)
Urinary frequency	1/551 (0.2%)		0/273 (0%)
Urinary tract disorder	2/551 (0.4%)		1/273 (0.4%)
Urinary tract infection	33/551 (6%)		12/273 (4.4%)
Reproductive system and breast disorders
Breast enlargement	1/551 (0.2%)		0/273 (0%)
Dysmenorrhea	0/551 (0%)		1/273 (0.4%)
Endometrial hyperplasia	1/551 (0.2%)		0/273 (0%)
Menorrhagia	3/551 (0.5%)		1/273 (0.4%)
Unintended pregnancy	1/551 (0.2%)		1/273 (0.4%)
Respiratory, thoracic and mediastinal disorders
Apnea	0/551 (0%)		1/273 (0.4%)
Aspiration pneumonia	1/551 (0.2%)		0/273 (0%)
Asthma	1/551 (0.2%)		0/273 (0%)
Bronchitis	9/551 (1.6%)		3/273 (1.1%)
Chronic obstructive airway disease	1/551 (0.2%)		0/273 (0%)
Cough increased	2/551 (0.4%)		0/273 (0%)
Dyspnea	13/551 (2.4%)		3/273 (1.1%)
Epistaxis	2/551 (0.4%)		0/273 (0%)
Hemoptysis	1/551 (0.2%)		0/273 (0%)
Interstitial pneumonia	2/551 (0.4%)		0/273 (0%)
Lung disorder	7/551 (1.3%)		1/273 (0.4%)
Lung edema	2/551 (0.4%)		0/273 (0%)
Lung infiltration	3/551 (0.5%)		0/273 (0%)
Mediastinitis	1/551 (0.2%)		0/273 (0%)
Pharyngitis	7/551 (1.3%)		2/273 (0.7%)
Plural effusion	7/551 (1.3%)		1/273 (0.4%)
Pluritic pain	1/551 (0.2%)		0/273 (0%)
Pneumonia	57/551 (10.3%)		11/273 (4%)
Pneumonitis	5/551 (0.9%)		0/273 (0%)
Pneumothorax	1/551 (0.2%)		1/273 (0.4%)
Respiratory disorder general	1/551 (0.2%)		0/273 (0%)
Respiratory failure	2/551 (0.4%)		1/273 (0.4%)
Rhinitis	0/551 (0%)		1/273 (0.4%)
Sinusitis	4/551 (0.7%)		1/273 (0.4%)
Upper respiratory infection	2/551 (0.4%)		1/273 (0.4%)
Skin and subcutaneous tissue disorders
Acne	1/551 (0.2%)		0/273 (0%)
Angioedema	1/551 (0.2%)		0/273 (0%)
Exfoliative dermatitis	2/551 (0.4%)		0/273 (0%)
Fungal dermatitis	1/551 (0.2%)		0/273 (0%)
Herpes simplex	5/551 (0.9%)		0/273 (0%)
Herpes zoster	6/551 (1.1%)		2/273 (0.7%)
Maculopapular rash	1/551 (0.2%)		0/273 (0%)
Pruritus	2/551 (0.4%)		0/273 (0%)
Rash	4/551 (0.7%)		1/273 (0.4%)
Skin benign neoplasm	0/551 (0%)		1/273 (0.4%)
Skin disorder general	2/551 (0.4%)		2/273 (0.7%)
Skin necrosis	4/551 (0.7%)		0/273 (0%)
Skin ulcer	7/551 (1.3%)		1/273 (0.4%)
Sweating	1/551 (0.2%)		0/273 (0%)
Vascular disorders
Arterial anomaly	4/551 (0.7%)		1/273 (0.4%)
Cerebral ischemia	0/551 (0%)		2/273 (0.7%)
Cerebrovascular accident	5/551 (0.9%)		3/273 (1.1%)
Deep vein thrombosis	8/551 (1.5%)		3/273 (1.1%)
Embolus	1/551 (0.2%)		1/273 (0.4%)
Hemorrhage	2/551 (0.4%)		1/273 (0.4%)
Hypervolemia	5/551 (0.9%)		1/273 (0.4%)
Hypovolemia	3/551 (0.5%)		1/273 (0.4%)
Occlusion	1/551 (0.2%)		0/273 (0%)
Peripherial gangrene	2/551 (0.4%)		1/273 (0.4%)
Peripherial vascual disorder	6/551 (1.1%)		4/273 (1.5%)
Phlebitis	1/551 (0.2%)		0/273 (0%)
Subarachnoid hemorrhage	2/551 (0.4%)		0/273 (0%)
Thrombophlebitis	4/551 (0.7%)		3/273 (1.1%)
Thrombosis	2/551 (0.4%)		3/273 (1.1%)
Vascular disorder	2/551 (0.4%)		0/273 (0%)
Other (Not Including Serious) Adverse Events
	SRL Conversion in Stable Renal Transplant Recipients		CNI Continuation in Stable Renal Transplant Recipients
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	545/551 (98.9%)		264/273 (96.7%)
Blood and lymphatic system disorders
Anemia	219/551 (39.7%)		61/273 (22.3%)
Ecchymosis	28/551 (5.1%)		5/273 (1.8%)
Iron deficiency anemia	32/551 (5.8%)		3/273 (1.1%)
Leukopenia	75/551 (13.6%)		13/273 (4.8%)
Thrombocytopenia	79/551 (14.3%)		10/273 (3.7%)
Cardiac disorders
Hypertension	127/551 (23%)		68/273 (24.9%)
Endocrine disorders
Diabetes mellitus	33/551 (6%)		12/273 (4.4%)
Gastrointestinal disorders
Anorexia	33/551 (6%)		11/273 (4%)
Aphthous stomatitis	49/551 (8.9%)		3/273 (1.1%)
Constipation	32/551 (5.8%)		15/273 (5.5%)
Diarrhea	234/551 (42.5%)		75/273 (27.5%)
Dyspepsia	35/551 (6.4%)		21/273 (7.7%)
Gastritis	21/551 (3.8%)		14/273 (5.1%)
Gum hyperplasia	1/551 (0.2%)		15/273 (5.5%)
Liver function tests abnormal	38/551 (6.9%)		4/273 (1.5%)
Mouth ulceration	34/551 (6.2%)		1/273 (0.4%)
Nausea	69/551 (12.5%)		27/273 (9.9%)
Stomatitis	59/551 (10.7%)		3/273 (1.1%)
Vomiting	72/551 (13.1%)		38/273 (13.9%)
Gastroenteritis	68/551 (12.3%)		22/273 (8.1%)
General disorders
Abdominal pain	87/551 (15.8%)		42/273 (15.4%)
Accidental injury	98/551 (17.8%)		39/273 (14.3%)
Asthenia	75/551 (13.6%)		30/273 (11%)
Back pain	46/551 (8.3%)		37/273 (13.6%)
Chest pain	42/551 (7.6%)		23/273 (8.4%)
Cyst	30/551 (5.4%)		13/273 (4.8%)
Face edema	32/551 (5.8%)		2/273 (0.7%)
Fever	125/551 (22.7%)		28/273 (10.3%)
Flu syndrome	25/551 (4.5%)		14/273 (5.1%)
Headache	111/551 (20.1%)		43/273 (15.8%)
Lab test abnormal	38/551 (6.9%)		15/273 (5.5%)
Pain	82/551 (14.9%)		38/273 (13.9%)
Transplant rejection	32/551 (5.8%)		14/273 (5.1%)
Cellulitis	31/551 (5.6%)		6/273 (2.2%)
Flu Syndrome	62/551 (11.3%)		30/273 (11%)
Infection	177/551 (32.1%)		71/273 (26%)
Sepsis	28/551 (5.1%)		6/273 (2.2%)
Injury, poisoning and procedural complications
Local reaction to procedure	42/551 (7.6%)		25/273 (9.2%)
Metabolism and nutrition disorders
Acidosis	28/551 (5.1%)		15/273 (5.5%)
BUN increased	34/551 (6.2%)		13/273 (4.8%)
Creatinine increased	113/551 (20.5%)		48/273 (17.6%)
Dehydration	35/551 (6.4%)		6/273 (2.2%)
Edema	62/551 (11.3%)		18/273 (6.6%)
Gout	29/551 (5.3%)		15/273 (5.5%)
Hypercalcemia	5/551 (0.9%)		15/273 (5.5%)
Hypercholesteremia	245/551 (44.5%)		44/273 (16.1%)
Hyperglycemia	76/551 (13.8%)		20/273 (7.3%)
Hyperkalemia	13/551 (2.4%)		19/273 (7%)
Hyperlipemia	317/551 (57.5%)		83/273 (30.4%)
Hyperuricemia	46/551 (8.3%)		48/273 (17.6%)
Hypokalemia	57/551 (10.3%)		8/273 (2.9%)
Lactic dehydrogenase increased	70/551 (12.7%)		6/273 (2.2%)
Peripheral edema	190/551 (34.5%)		51/273 (18.7%)
SGOT increased	42/551 (7.6%)		2/273 (0.7%)
SGPT increased	47/551 (8.5%)		4/273 (1.5%)
Weight loss	29/551 (5.3%)		11/273 (4%)
Musculoskeletal and connective tissue disorders
Arthralgia	91/551 (16.5%)		55/273 (20.1%)
Myalgia	38/551 (6.9%)		12/273 (4.4%)
Nervous system disorders
Anxiety	28/551 (5.1%)		5/273 (1.8%)
Depression	31/551 (5.6%)		14/273 (5.1%)
Dizziness	37/551 (6.7%)		16/273 (5.9%)
Insomnia	39/551 (7.1%)		16/273 (5.9%)
Renal and urinary disorders
Albuminuria	166/551 (30.1%)		45/273 (16.5%)
Amenorrhea	15/168 (8.9%)		1/81 (1.2%)
Dysuria	30/551 (5.4%)		10/273 (3.7%)
Hematuria	33/551 (6%)		11/273 (4%)
Impotence	24/383 (6.3%)		7/192 (3.6%)
Kidney function abnormal	73/551 (13.2%)		47/273 (17.2%)
Menorrhagia	12/168 (7.1%)		2/81 (2.5%)
Metrorrhagia	12/168 (7.1%)		5/81 (6.2%)
Urinary Tract Infection	127/551 (23%)		58/273 (21.2%)
Reproductive system and breast disorders
Ovarian cyst	14/168 (8.3%)		4/81 (4.9%)
Respiratory, thoracic and mediastinal disorders
Cough increased	100/551 (18.1%)		40/273 (14.7%)
Dyspnea	54/551 (9.8%)		22/273 (8.1%)
Epistaxis	52/551 (9.4%)		4/273 (1.5%)
Pharyngitis	53/551 (9.6%)		18/273 (6.6%)
Rhinitis	48/551 (8.7%)		18/273 (6.6%)
Bronchitis	51/551 (9.3%)		17/273 (6.2%)
Pharyngitis	75/551 (13.6%)		27/273 (9.9%)
Pneumonia	88/551 (16%)		17/273 (6.2%)
Sinusitis	49/551 (8.9%)		25/273 (9.2%)
Upper Respiratory Infection	105/551 (19.1%)		49/273 (17.9%)
Skin and subcutaneous tissue disorders
Acne	93/551 (16.9%)		11/273 (4%)
Pruritus	34/551 (6.2%)		5/273 (1.8%)
Rash	73/551 (13.2%)		14/273 (5.1%)
Skin disorder	26/551 (4.7%)		18/273 (6.6%)
Fungal Dermatitis	48/551 (8.7%)		16/273 (5.9%)
Herpes Simplex	61/551 (11.1%)		14/273 (5.1%)
Herpes Zoster	20/551 (3.6%)		15/273 (5.5%)
Skin Carcinoma	18/551 (3.3%)		24/273 (8.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.

Results Point of Contact

Name/Title	U. S. Contact Center
Organization	Wyeth
Phone
Email	clintrialresults@wyeth.com

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00038948

Other Study ID Numbers:

0468H1-316

First Posted:

Jun 7, 2002

Last Update Posted:

May 14, 2010

Last Verified:

Apr 1, 2010

Study Comparing Conversion to Sirolimus vs. Continued Use of Calcineurin Inhibitors in Kidney Transplant Recipients

Study Details

Study Description

Brief Summary

Study Design

Arms and Interventions

Outcome Measures

Primary Outcome Measures

Secondary Outcome Measures

Eligibility Criteria

Criteria

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

Sponsors and Collaborators

Investigators

Study Documents (Full-Text)

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Publications

Study Results

Participant Flow

Baseline Characteristics

Outcome Measures

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Outcome Measure Data

Statistical Analysis 1

Statistical Analysis 2

Adverse Events

All Cause Mortality

Serious Adverse Events

Other (Not Including Serious) Adverse Events

Limitations/Caveats

More Information

Certain Agreements

Results Point of Contact