Mycophenolate Mofetil (MMF) for Treatment of Chronic Graft-versus-host Disease (GVHD)

• Sponsor: Martin, Paul (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00089141
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 151
• Locations: 16
• Arms: 2
• Duration (Months): 52
• Patients Per Site: 9.4
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

RATIONALE: Mycophenolate mofetil added to immunosuppressive treatment regimens may be effective in treating newly diagnosed chronic graft-versus-host disease caused by stem cell transplantation. It is not yet known whether immunosuppressive treatment regimens are more effective with or without mycophenolate mofetil in treating chronic graft-versus-host disease.

PURPOSE: This randomized phase III trial is studying whether the addition of mycophenolate mofetil improves the efficacy of immunosuppressive treatment regimens in patients with newly diagnosed chronic graft-versus-host disease.

Condition or Disease	Intervention/Treatment	Phase
Cancer	Drug: mycophenolate mofetil; Drug: placebo	Phase 3

Detailed Description

OBJECTIVES:

• Compare the efficacy of immunosuppressive treatment regimens with vs without mycophenolate mofetil in patients with newly diagnosed chronic graft-vs-host disease.

• Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, double-blind, placebo-controlled, prospective, multicenter study. Patients are stratified according to organ involvement of chronic graft-versus-host disease (GVHD) (single organ vs multiple organs) and transplant center. Patients are randomized to 1 of 2 treatment arms.

All patients receive usual therapy for chronic GVHD comprising oral prednisone twice daily and oral cyclosporine, oral tacrolimus or oral sirolimus twice daily until 2 weeks after the first evidence of improvement of symptoms of chronic GVHD.

• Arm I: Patients receive oral mycophenolate mofetil twice daily.

• Arm II: Patients receive oral placebo twice daily. In both arms administration of the study drug continues for 3 months after completion of prednisone and cyclosporine, tacrolimus or sirolimus in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then every 3 months.

Patients are followed every 3 months for 3-5 years.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 3 years.

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized Study to Evaluate The Efficacy of Mycophenolate Mofetil Added to The Systemic Immunosuppressive Regimen First Used For Treatment of Chronic Graft-Versus-Host Disease
• Study Start Date: May 1, 2004
• Actual Primary Completion Date: Jul 1, 2008
• Actual Study Completion Date: Sep 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Mycophenolate mofetil Patients receive oral mycophenolate mofetil twice daily.	Drug: mycophenolate mofetil; Given orally; Other Names: CellCept
Placebo Comparator: Placebo Patients receive oral placebo twice daily	Drug: placebo; Given orally; Other Names: Control

Outcome Measures

Primary Outcome Measures

1. Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy [2 years]

   Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy

Secondary Outcome Measures

1. Definitive Absence of Efficacy Success [2 years]

   Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy

2. Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy [2 years]

   Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease

3. Bronchiolitis Obliterans [within 4 years]

   Development of bronchiolitis obliterans during treatment

4. Recurrent Malignancy [within 4 years]

   Development of recurrent malignancy after enrollment in the study

5. Non-relapse Mortality [within 4 years]

   Death without prior development of recurrent malignancy

6. Death or Recurrent Malignancy [within 4 years]

   Death due to any cause or development of recurrent malignancy at any time after enrollment

7. Death [within 4 years]

   Death from any cause after enrollment in the study

8. Withdrawal of Prednisone [within 4 years]

   Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD

9. End of Systemic Treatment [within 4 years]

   Withdrawal of all immunosuppressive treatment without recurrent malignancy

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

DISEASE CHARACTERISTICS:

• Newly diagnosed chronic-graft-versus host disease (GVHD)

• Systemic immunosuppressive treatment indicated AND no contraindication to treatment with mycophenolate mofetil

• Has undergone prior transplantation with any type of donor, hematopoietic stem cell graft, or conditioning regimen

• No clinical, laboratory, or image-based evidence known to be present at the time of enrollment and indicating a high probability of subsequent recurrent or progressive disease

PATIENT CHARACTERISTICS:

Age

• Any age

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Absolute neutrophil count ≥ 1,500/mm^3

Hepatic

• Not specified

Renal

• Not specified

Pulmonary

• No known bronchiolitis obliterans as a manifestation of chronic GVHD

Immunologic

• No fungal infection without radiographic evidence of improvement during continued antifungal therapy

• No cytomegalovirus (CMV) pneumonia without major radiographic evidence of improvement

• No other CMV infection without reduction of antigenemia or viral load during continued antiviral therapy

• No active disseminated varicella zoster viral infection

• No known hypersensitivity or allergy to MMF

Gastrointestinal

• Able to tolerate oral medication

• No lactose-intolerant children who are too young to swallow capsules

• No frank blood from the rectum

• No melena

• No known gastrointestinal ulceration

Other

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception

• Female patients must use 2 forms of contraception 4 weeks prior to, during, and for 6 weeks after completion of study treatment

• Not hospitalized at time of enrollment

• No rare, hereditary deficiency of hypoxanthine-guanine phosphoribosyl-transferase (HGPRT)

PRIOR CONCURRENT THERAPY:

Biologic therapy

• See Disease Characteristics

Chemotherapy

• Not specified

Endocrine therapy

• Prior treatment with prednisone or equivalent allowed provided the dose was ≤ 1.0 mg/kg/day at the time of enrollment

• Concurrent systemic glucocorticoids allowed

Radiotherapy

• Not specified

Surgery

• Not specified

Other

• Prior mycophenolate mofetil (MMF) for prevention or treatment of acute GVHD allowed provided MMF was discontinued at least 2 weeks before the diagnosis of chronic GVHD was made

• No prior systemic treatment for chronic GVHD

• No prior treatment for chronic GVHD

• Concurrent antacids allowed provided there is at least a 2-hour interval before and after administration of MMF

• No other concurrent systemic immunosuppressive treatment except cyclosporine, tacrolimus or sirolimus

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	City of Hope Comprehensive Cancer Center	Duarte	California	United States	91010-3000
2	Stanford Cancer Center	Stanford	California	United States	94305-5824
3	University of Florida Shands Cancer Center	Gainesville	Florida	United States	32610-100277
4	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637-1470
5	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942
6	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455
7	UNMC Eppley Cancer Center at the University of Nebraska Medical Center	Omaha	Nebraska	United States	68198-3330
8	Hackensack University Medical Center Cancer Center	Hackensack	New Jersey	United States	07601
9	Oregon Health and Science University Cancer Institute	Portland	Oregon	United States	97239-3098
10	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee	United States	37232-6838
11	Baylor University Medical Center - Dallas	Dallas	Texas	United States	75246
12	M. D. Anderson Cancer Center at University of Texas	Houston	Texas	United States	77030-4009
13	Texas Transplant Institute	San Antonio	Texas	United States	78229
14	Fred Hutchinson Cancer Research Center	Seattle	Washington	United States	98109-1024
15	University of Washington School of Medicine	Seattle	Washington	United States	98195
16	Princess Margaret Hospital	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

• Martin, Paul
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Paul J. Martin, MD, Fred Hutchinson Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Martin, Paul, Member, Fred Hutchinson Cancer Center
• ClinicalTrials.gov Identifier: NCT00089141
• Other Study ID Numbers: 1697.00; FHCRC-1697.00; ROCHE-FHCRC-1697.00; UMN-2004UC007; CDR0000378054
• First Posted: Aug 5, 2004
• Last Update Posted: May 3, 2013
• Last Verified: Aug 1, 2009

• Keywords provided by Martin, Paul, Member, Fred Hutchinson Cancer Center: graft versus host disease; accelerated phase chronic myelogenous leukemia; adult acute lymphoblastic leukemia in remission; adult acute myeloid leukemia in remission; childhood acute lymphoblastic leukemia in remission; childhood acute myeloid leukemia in remission; atypical chronic myeloid leukemia; blastic phase chronic myelogenous leukemia; childhood chronic myelogenous leukemia; chronic eosinophilic leukemia; chronic idiopathic myelofibrosis; chronic myelomonocytic leukemia; chronic neutrophilic leukemia; chronic phase chronic myelogenous leukemia; de novo myelodysplastic syndromes; disseminated neuroblastoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue; juvenile myelomonocytic leukemia; myelodysplastic/myeloproliferative disease, unclassifiable; nodal marginal zone B-cell lymphoma; noncontiguous stage II adult Burkitt lymphoma; noncontiguous stage II adult diffuse large cell lymphoma; noncontiguous stage II adult diffuse mixed cell lymphoma; noncontiguous stage II adult diffuse small cleaved cell lymphoma; noncontiguous stage II adult immunoblastic large cell lymphoma; noncontiguous stage II adult lymphoblastic lymphoma; noncontiguous stage II grade 1 follicular lymphoma; noncontiguous stage II grade 2 follicular lymphoma; noncontiguous stage II grade 3 follicular lymphoma; noncontiguous stage II mantle cell lymphoma; noncontiguous stage II marginal zone lymphoma; noncontiguous stage II small lymphocytic lymphoma; poor prognosis metastatic gestational trophoblastic tumor; previously treated childhood rhabdomyosarcoma; previously treated myelodysplastic syndromes; secondary acute myeloid leukemia; secondary myelodysplastic syndromes; splenic marginal zone lymphoma; stage I multiple myeloma; stage II multiple myeloma; stage II ovarian epithelial cancer; stage III adult Burkitt lymphoma; stage III adult diffuse large cell lymphoma; stage III adult diffuse mixed cell lymphoma; stage III adult diffuse small cleaved cell lymphoma; stage III adult immunoblastic large cell lymphoma; stage III adult lymphoblastic lymphoma; stage III chronic lymphocytic leukemia; stage III grade 1 follicular lymphoma; stage III grade 2 follicular lymphoma; stage III grade 3 follicular lymphoma; stage III mantle cell lymphoma; stage III marginal zone lymphoma; stage III multiple myeloma; stage III ovarian epithelial cancer; stage III small lymphocytic lymphoma; stage III malignant testicular germ cell tumor; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV adult Burkitt lymphoma; stage IV adult diffuse large cell lymphoma; stage IV adult diffuse mixed cell lymphoma; stage IV adult diffuse small cleaved cell lymphoma; stage IV adult immunoblastic large cell lymphoma; stage IV adult lymphoblastic lymphoma; stage IV breast cancer; stage IV chronic lymphocytic leukemia; stage IV grade 1 follicular lymphoma; stage IV grade 2 follicular lymphoma; stage IV grade 3 follicular lymphoma; stage IV mantle cell lymphoma; stage IV marginal zone lymphoma; stage IV ovarian epithelial cancer; stage IV small lymphocytic lymphoma; childhood myelodysplastic syndromes
• Additional relevant MeSH terms: Graft vs Host Disease; Mycophenolic Acid

Study Results

Participant Flow

Recruitment Details	Clinic patients were recruited from May 2004 through June 2008.

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Period Title: Overall Study
STARTED	74	77
COMPLETED	56	53
NOT COMPLETED	18	24

Baseline Characteristics

Arm/Group Title	Mycophenolate Mofetil	Placebo	Total
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily	Total of all reporting groups
Overall Participants	74	77	151
Age (Count of Participants)
<=18 years	1 1.4%	1 1.3%	2 1.3%
Between 18 and 65 years	68 91.9%	71 92.2%	139 92.1%
>=65 years	5 6.8%	5 6.5%	10 6.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	48.3 (13.3)	47.9 (13.3)	48.1 (13.3)
Sex: Female, Male (Count of Participants)
Female	33 44.6%	37 48.1%	70 46.4%
Male	41 55.4%	40 51.9%	81 53.6%
Region of Enrollment (participants) [Number]
United States	73 98.6%	75 97.4%	148 98%
Canada	1 1.4%	2 2.6%	3 2%

Outcome Measures

1. Primary Outcome

Title	Cure of Chronic GVHD Without Resorting to Secondary Systemic Therapy
Description	Withdrawal of all systemic immunosuppressive treatment after resolution of chronic GVHD, before death or onset of recurrent malignancy
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	11 14.9%	10 13%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.22
	Comments	P values are 2 sided and are based on likelihood ratio statistics.
	Method	Regression, Cox
	Comments	Analysis for all endpoints was stratified by number of affected organs and type of conditioning regimen.
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.66
	Confidence Interval	() 95%; 0.7 to 3.7
	Parameter Dispersion	Type: Value:
	Estimation Comments	For all analyses, MMF arm in numerator, and placebo arm in denominator. Hazard ratio estimate includes 3 efficacy success events that occurred after two years in the placebo arm.

2. Secondary Outcome

Title	Definitive Absence of Efficacy Success
Description	Administration of secondary systemic therapy for chronic GVHD, death during primary therapy, or onset of recurrent malignancy or bronchiolitis obliterans during primary therapy
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	45 60.8%	40 51.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.03
	Comments
	Method	Regression, Cox
	Comments	Statistical analysis did not count treatment continuing beyond 2 years as efficacy failure (n = 2 in each arm).
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.65
	Confidence Interval	() 95%; 1.1 to 2.6
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Open Label Systemic Treatment Because of Inadequate Response to Primary Therapy
Description	Administration of any systemic therapy other than the immunosuppressive agents used for initial treatment, because of persistent or progressive chronic graft-versus-host disease
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	24 32.4%	25 32.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.55
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.19
	Confidence Interval	() 95%; 0.7 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Bronchiolitis Obliterans
Description	Development of bronchiolitis obliterans during treatment
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	5 6.8%	4 5.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.48
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.61
	Confidence Interval	() 95%; 0.4 to 6.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Recurrent Malignancy
Description	Development of recurrent malignancy after enrollment in the study
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	17 23%	10 13%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.17
	Comments
	Method	Regression, Cox
	Comments	adjusted for risk category
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.74
	Confidence Interval	() 95%; 0.8 to 3.9
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Non-relapse Mortality
Description	Death without prior development of recurrent malignancy
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	8 10.8%	5 6.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.41
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.62
	Confidence Interval	() 95%; 0.5 to 5.0
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Death or Recurrent Malignancy
Description	Death due to any cause or development of recurrent malignancy at any time after enrollment
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	25 33.8%	15 19.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.14
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.69
	Confidence Interval	() 95%; 0.9 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Death
Description	Death from any cause after enrollment in the study
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	19 25.7%	10 13%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.10
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.99
	Confidence Interval	() 95%; 0.9 to 4.3
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Withdrawal of Prednisone
Description	Withdrawal of treatment with prednisone after improvement or resolution of chronic GVHD
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	30 40.5%	33 42.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.34
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.28
	Confidence Interval	() 95%; .08 to 2.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	End of Systemic Treatment
Description	Withdrawal of all immunosuppressive treatment without recurrent malignancy
Time Frame	within 4 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Mycophenolate Mofetil	Placebo
Arm/Group Description	Patients receive oral mycophenolate mofetil 1000 mg twice daily.	Patients receive oral placebo twice daily
Measure Participants	74	77
Number [participants]	15 20.3%	15 19.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Mycophenolate Mofetil, Placebo
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.28
	Comments
	Method	Regression, Cox
	Comments
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	1.51
	Confidence Interval	() 95%; 0.7 to 3.2
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT 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.