## Protocol Section
### Identification Module
**NCT ID:** NCT00784979

**Brief Title:** Panel Reactive Antibody (PRA) Reduction in Sensitized Patients Awaiting Renal Transplantation

**Official Title:** Reduction of PRA (Panel Reactive Antibody) in Sensitized Patients Awaiting Live-Donor Renal Transplantation

#### Organization Study ID Info
**ID:** IIS_100109
#### Organization
**Class:** OTHER
**Full Name:** Tampa General Hospital
### Status Module
#### Completion Date
**Date:** 2012-04

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-06-29

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-06-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2010-12

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-06-29

**Type:** ESTIMATED

**Results First Submit Date:** 2014-04-28

**Results First Submit QC Date:** 2015-06-22

#### Start Date
**Date:** 2002-01

**Status Verified Date:** 2015-06

#### Study First Post Date
**Date:** 2008-11-05
**Type:** ESTIMATED
**Study First Submit Date:** 2008-11-04
**Study First Submit QC Date:** 2008-11-04
### Sponsor Collaborators Module

#### Collaborators

**Class:** INDUSTRY

**Name:** CSL Behring

#### Lead Sponsor

**Class:** OTHER

**Name:** Tampa General Hospital

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to offer Panel Reactive Antibodies \[PRA\] reduction treatment to high responder renal transplant patients who otherwise may never be compatible with a potential organ donor. PRA reduction is offered in the following phases:

1. Immunological Testing
2. Transplant Nephrectomy
3. Pharmacologic Therapy
4. Plasmapheresis
5. Transplant

**Detailed Description:** Patients with high level of preformed antibodies (panel reactive antibodies \[PRA\]) to donor antigens make identification of a suitable donor difficult. For most transplant centers, 20-35% of patients waiting for a kidney transplant comprise this challenging group. These patients have a wait time of over five years and have many incompatible cross-matches with potential organ donors.

### Conditions Module

**Conditions:**

- End Stage Renal Disease

**Keywords:**

- Renal

- Transplant

- PRA

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 26

**Type:** ACTUAL

**Phases:**

- PHASE4

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis

**Intervention Names:**

- Drug: CMVIG

**Label:** CMVIG followed by PP

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CMVIG followed by PP

**Description:** 400mg/kg IV (60mg/kg/IV/hr initially, titrated up) once a week up to four weeks

**Name:** CMVIG

**Other Names:**

- Cytomegalovirus Immune Globulin - Intravenous

- Cytogam

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Description:** The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.

**Measure:** The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor

**Time Frame:** four weeks

#### Secondary Outcomes

**Measure:** Monitor Graft Survival

**Time Frame:** 5 years

**Measure:** Monitor Patient Survival

**Time Frame:** 5 years

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Renal transplant recipients with a potential living donor who is incompatible (T-\&/or B-cell locus) due to recipient high PRA or MHC antibodies
* PRA greater than or equal to 20% within last twelve months
* Recipient and donor accepted as potential candidates by the LifeLink Healthcare Renal Transplant Committee

Exclusion Criteria:

* Patients with known allergy to CytoGam(R), Cellcept, Rapamycin
* Patients who will receive IVIG or CytoGam(R) for any cause prior to protocol process
* ABO incompatibility
* Patients not capable of following through the treatment for various reasons as determined by treating physicians
* Any potential recipient who is pregnant or becomes pregnant
* Exclusion for Plasmapheresis: known allergy to ethylene oxide or natural rubber latex.
* Exclusion for Plasmapheresis: Intake of ACE-inhibitor or Angtiotensiin-receptor blockers in the last 24 hours prior to plasma exchange

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Tampa

**Country:** United States

**Facility:** LifeLink HealthCare Institute

**State:** Florida

**Zip:** 33606

#### Overall Officials

**Official 1:**

**Affiliation:** Lifelink Healthcare Institute

**Name:** John Leone, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### See Also Links

**Label:** Tampa General Medical Group

**URL:** http://www.tgmg.org

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007674

- Term: Kidney Diseases

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Ancestors

- ID: D000007155

- Term: Immunologic Factors

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

### Intervention Browse Module - Browse Leaves

- ID: M4225

- Name: Antibodies

- Relevance: LOW

- As Found: Unknown

- ID: M21960

- Name: Sirolimus

- Relevance: LOW

- As Found: Unknown

- ID: M10184

- Name: Immunoglobulins

- Relevance: HIGH

- As Found: Cap

- ID: M19117

- Name: Immunoglobulins, Intravenous

- Relevance: LOW

- As Found: Unknown

- ID: M8836

- Name: gamma-Globulins

- Relevance: LOW

- As Found: Unknown

- ID: M20191

- Name: Rho(D) Immune Globulin

- Relevance: LOW

- As Found: Unknown

- ID: M353695

- Name: Temsirolimus

- Relevance: LOW

- As Found: Unknown

- ID: M2827

- Name: MTOR Inhibitors

- Relevance: LOW

- As Found: Unknown

- ID: M10201

- Name: Immunologic Factors

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007136

- Term: Immunoglobulins

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

#### Event Groups

**Group ID:** EG000

**Title:** Highly Sensitized Patients

**Description:** Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.

**ID:** EG000

**Other Num at Risk:** 20

**Serious Number At Risk:** 20

**Title:** Highly Sensitized Patients

**Frequency Threshold:** 0

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 26

**Units:** Participants

### Group

**ID:** BG000

**Title:** Highly Sensitized Patients

**Description:** Highly-sensitized patients were defined as those having PRA \>/= 20% within the last 12 months; identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 10.6

**Value:** 42

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 13

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 13

**Category Title:** Male

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 76

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Description:** \>/= 18 years old
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
### Measure 3
**Parameter Type:** NUMBER
**Title:** Percent of subjects with PRA >/= 20% in last 12 months
**Unit of Measure:** percent of subjects with elevated PRA
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** jpleone@tgh.org
**Organization:** Tampa General Hospital
**Phone:** 813-844-5666
**Title:** Dr. John Leone
## Results Section - Outcome Measures Module
### Outcome Measure 1
### Outcome Measure 2
### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 40
**Title:** 
#### Outcome Measure 2
#### Outcome Measure 3
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Description:** The percent of sensitized patients treated with PRA Reduction Pharmacological Therapy, including Cytogam, who become cross-match compatible with potential living donor. Treatment success defined as achieving a decrease in donor specific antibody and eliminating cross-match incompatibility sufficient to allow transplantation.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** four weeks
**Title:** The Percent of Sensitized Patients Treated With PRA Reduction Pharmacological Therapy, Including Cytogam, Who Become Cross-match Compatible With Potential Living Donor
**Type:** PRIMARY
**Unit of Measure:** percent of subjects becoming compatible
##### Group
**Description:** Highly-sensitized patients were defined as those having PRA greater than or equal to 20 percent within the last 12 months, identification of donor-specific antibody or, any combination of Class I and/or Class 2 HLA incompatibility.
**ID:** OG000
**Title:** Highly Sensitized Patients
#### Outcome Measure 2
**Reporting Status:** NOT_POSTED
**Time Frame:** 5 years
**Title:** Monitor Graft Survival
**Type:** SECONDARY
#### Outcome Measure 3
**Reporting Status:** NOT_POSTED
**Time Frame:** 5 years
**Title:** Monitor Patient Survival
**Type:** SECONDARY
### Participant Flow Module
#### Group
**Description:** MMF or rapamycin was given with CMVIG for 4 weeks followed by plasmapheresis
**ID:** FG000
**Title:** CMVIG Followed by PP
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** incomplete data
###### Reason
**Group ID:** FG000
**Number of Subjects:** 6
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 26
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 20
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 6
**Has Results:** True