Safety Outcomes of Lower Immunosuppression Versus Traditional Immunosuppression in Heart Transplant Recipients

NCT00299221 | Completed Phase 4 Results

• 1 other identifier: TICTAC
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

Brief Summary

This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.

Conditions

Immunosuppression

Keywords

immunosuppression; steroid withdrawal; rejection; coronary disease; cytomegalovirus infection

Outcome Measures

Primary Outcomes (1)

• Mean International Society for Heart and Lung Transplantation Biopsy Score Over the First 6 Months Post-transplantation

  Mean ISHLT biopsy score Biopsies of the heart may be various grades and each is assigned a numerical score. Grade 0 is 0 points, 1A = 1, 1B = 2, grade 2 = 3, grade 3A = 4, Grade 3B = 5, and grade 4 = 6 units. The mean biopsy score is the numeric average of the biopsy scores for the first 6 post-transplant months. Best value is 0, worst score is 6.

  6 months

Secondary Outcomes (4)

• Percent of Patients Alive at One Year Post-transplant

  1 year

• Number of Patients With Cytomegalovirus (CMV) at One Year Post-transplant

  1 year

• Number of Patients With Allograft Vasculopathy (CAD) at One Year Post Transplant

  1 year

• Mean ISHLT Biopsy Score Over First Year Post-transplant

  1 year

Study Arms (2)

Monotherapy

ACTIVE COMPARATOR

Tacrolimus alone

Drug: Tacrolimus

Combination therapy

ACTIVE COMPARATOR

tacrolimus with mycophenolate mofetil

Drug: Tacrolimus; Drug: combination therapy

Interventions

Tacrolimus DRUG

tacrolimus

Also known as: Prograf

Combination therapy; Monotherapy

combination therapy DRUG

MMF

Also known as: mycophenolate mofetil / CellCept

Combination therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (at least 18 years old)
• Undergoing a first heart transplant (no heart/kidney transplants), who receive their transplant at one of the study sites
• Specifically INCLUDED are patients on ventricular assist devices, and allosensitized recipients

You may not qualify if:

• Age less than 18
• Inability to provide proper informed consent
• Combined organ transplantation
• Re-Transplantation

Sponsors & Collaborators

• Newark Beth Israel Medical Center: lead
• Astellas Pharma Inc: collaborator

Study Sites (2)

Newark Beth Israel Medical Center

Newark, New Jersey, 07112, United States

Location

Mt. Sinai Cardiovascular Institute

New York, New York, 10029, United States

Location

Related Publications (2)

• Baran DA, Zucker MJ, Arroyo LH, Alwarshetty MM, Ramirez MR, Prendergast TW, Goldstein DJ, Camacho M, Gass AL, Carr C, Cohen M. Randomized trial of tacrolimus monotherapy: tacrolimus in combination, tacrolimus alone compared (the TICTAC trial). J Heart Lung Transplant. 2007 Oct;26(10):992-7. doi: 10.1016/j.healun.2007.07.022.

  PMID: 17919618 RESULT

• Baran DA, Zucker MJ, Arroyo LH, Camacho M, Goldschmidt ME, Nicholls SJ, Prevost-Fernandez J, Carr C, Adams L, Pardi S, Hou V, Binetti M, McCahill J, Chichetti J, Viloria V, Sanagustin MG, Ebuenga-Smith J, Mele L, Martin A, Blicharz D, Wolski K, Olesnicky L, Qian F, Gass AL, Cohen M. A prospective, randomized trial of single-drug versus dual-drug immunosuppression in heart transplantation: the tacrolimus in combination, tacrolimus alone compared (TICTAC) trial. Circ Heart Fail. 2011 Mar;4(2):129-37. doi: 10.1161/CIRCHEARTFAILURE.110.958520. Epub 2011 Jan 7.

  PMID: 21216835 RESULT

MeSH Terms

Conditions

Rejection, Psychology; Coronary Disease; Cytomegalovirus Infections

Interventions

Tacrolimus; Combined Modality Therapy; Mycophenolic Acid

Condition Hierarchy (Ancestors)

Social Behavior; Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Lactones; Organic Chemicals; Therapeutics; Caproates; Acids, Acyclic; Carboxylic Acids; Fatty Acids; Lipids

Limitations and Caveats

This trial enrolled 150 patients, but cannot be used to generalize care to other patients without careful consideration of risks and benefits. All patients had corticosteorids weaned so this trial doesn't assess the risk of steroid weaning.

Results Point of Contact

• Title: David Baran MD
• Organization: Newark Beth Israel Medical Center

dbaran@barnabashealth.org

973-926-7205

Study Officials

• David A Baran, MD

  Newark Beth Israel Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Heart Failure and Transplant Research

Study Record Dates

• First Submitted: March 2, 2006
• First Posted: March 6, 2006
• Study Start: April 1, 2004
• Primary Completion: June 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 28, 2015
• Results First Posted: May 28, 2015

Record last verified: 2015-05

Locations

US (2)