## Protocol Section
### Identification Module
**NCT ID:** NCT00214279

**Brief Title:** MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

**Official Title:** MMF Monotherapy and Immune Regulation in Kidney Transplant Recipients: Part 1 Steroid Withdrawal

#### Organization Study ID Info
**ID:** 2002-040
#### Organization
**Class:** OTHER
**Full Name:** University of Wisconsin, Madison
#### Secondary ID Infos
**ID:** CEL340
### Status Module
#### Completion Date
**Date:** 2007-11

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2012-06-26

**Type:** ESTIMATED

**Last Update Submit Date:** 2012-06-22

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2007-11

**Type:** ACTUAL

#### Start Date
**Date:** 2002-05

**Status Verified Date:** 2012-06

#### Study First Post Date
**Date:** 2005-09-21
**Type:** ESTIMATED
**Study First Submit Date:** 2005-09-14
**Study First Submit QC Date:** 2005-09-14
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Wisconsin, Madison

#### Responsible Party

**Type:** SPONSOR

### Description Module

**Brief Summary:** Part 1 of the study is to gradually withdraw steroids in a group of 50 older renal transplant recipients, converting then from the 3 drug regimen to a 2 drug regimen (cyclosporine and MMF), while carefully monitoring their graft function. 25 subjects would serve as control patients in the study and would remain on the 3 drug regimen (steroids, cyclosporine and MMF). Immunologic status will be determined before and after IS withdrawal using a delayed-type hypersensitivity (DTH) transfer test previously described in the original submission. Both the steroid withdrawal subjects and the control subjects will undergo the DTH testing throughout the 3 years of study participation.

### Conditions Module

**Conditions:**

- Renal Transplantation

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 32

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Remain on 3-drug standard of care immunosuppression including prednisone

**Label:** 1

**Type:** NO_INTERVENTION

#### Arm Group 2

**Description:** Corticosteroid withdrawal / prednisone taper over 14 weeks

**Intervention Names:**

- Drug: Corticosteroid withdrawal

**Label:** 2

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 2

**Description:** prednisone withdrawal, with maintenance mycophenolate mofetil therapy and either cyclosporine or tacrolimus

**Name:** Corticosteroid withdrawal

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**Measure:** Incidence of Allograft rejection

**Time Frame:** 3 years

#### Secondary Outcomes

**Measure:** Renal function as determined by serum creatinine

**Time Frame:** measure after 36 months

**Measure:** Allograft Survival

**Time Frame:** 3 years

**Description:** Research assay done to determine correlation between the status of donor specific regulation (DSR) and rates of rejection in both arms of the study.

**Measure:** Immunological function as determined by Trans-vivo delayed hypersensitivity assay (TV-DTH)

**Time Frame:** Day 0 (pre-transplant)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Patient who have received a kidney transplant during the "MMF era"
* Patients who have stable graft function indicated by a serum creatinine of \< 1.8 mg/dl, or a calculated creatinine clearance of \> 50 ml/minute

Exclusion Criteria:

* Patients who have had \> 1 rejection episode,
* Patients who have had a rejection episode within the past year;
* Patients who are steroid dependent due to pre-existing disease (for example, RA or SLE

**Minimum Age:** 55 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Madison

**Country:** United States

**Facility:** Unversity of Wisconsin

**State:** Wisconsin

**Zip:** 53792

#### Overall Officials

**Official 1:**

**Affiliation:** University of Wisconsin, Madison

**Name:** Hans Sollinger, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Infl

- Name: Anti-Inflammatory Agents

- Abbrev: ANeo

- Name: Antineoplastic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: Infe

- Name: Anti-Infective Agents

- Abbrev: ARhu

- Name: Antirheumatic Agents

- Abbrev: Derm

- Name: Dermatologic Agents

### Intervention Browse Module - Browse Leaves

- ID: M14121

- Name: Prednisone

- Relevance: LOW

- As Found: Unknown

- ID: M18961

- Name: Cyclosporine

- Relevance: LOW

- As Found: Unknown

- ID: M6730

- Name: Cyclosporins

- Relevance: LOW

- As Found: Unknown

- ID: M12128

- Name: Mycophenolic Acid

- Relevance: LOW

- As Found: Unknown

- ID: M18950

- Name: Tacrolimus

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
