A Study to Compare Treatment With Sirolimus Versus Standard Treatment in Patients Who Have Received a Kidney Transplant

NCT00005113 | Terminated Phase 3 DMC

• 2 other identifiers: DAIT SRL1DAIT 0468E1-217-US
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare treatment with the new drug sirolimus (SRL) versus the standard treatment with cyclosporine (CsA) or tacrolimus in children who have received kidney transplants. SRL is a new medication that may prevent the body's immune system from rejecting organ transplants. After receiving a kidney transplant, the body recognizes the donated kidney as a foreign invader and triggers the immune system to attack the kidney. This can lead to rejection of the new kidney and a failed transplant. To help reduce the risk of kidney rejection, transplant patients are given immunosuppressant drugs, which reduce the body's normal immune response and allow the transplanted organ to function. CsA or tacrolimus are two drugs that are often given to transplant patients. However, these are powerful drugs, and it can cause serious side effects and put a patient at increased risk for infections. SRL is a new drug that has been shown to reduce a transplant patient's chance of rejecting a new kidney, without serious side effects. This study is necessary to test the safety and effectiveness of SRL in children.

Conditions

End-Stage Renal Disease; Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

• Safety and efficacy of sirolimus

  Throughout study

Secondary Outcomes (6)

• Composite endpoint of biopsy proven acute rejection, graft loss, or death

  At Months 6, 12, and 24

• Rate of clinically diagnosed acute rejection

  At months 6, 12, 24, and 36

• Rate of change in glomerular filtration rate

  At Month 18

• Mean change in volume of allograft fibrosis

  At Months 6 and 18

• Intragraft expression of cytokines

  Throughout study

Study Arms (2)

1

EXPERIMENTAL

Participants will receive SRL, CsA/tacrolimus, and corticosteroids for up to 36 months

Drug: Cyclosporine; Drug: Sirolimus; Drug: Tacrolimus

2

EXPERIMENTAL

Participants will receive standard CsA or tacrolimus-based double or triple drug therapy for up to 36 months

Drug: Cyclosporine; Drug: Tacrolimus

Interventions

Cyclosporine DRUG

Oral tablet taken daily. Dosage is dependent on weight and is titrated to target trough level.

Also known as: CsA

1; 2

Sirolimus DRUG

Dosage in liquid or tablet form is dependent on body surface area and is titrated to target trough level.

Also known as: SRL

1

Tacrolimus DRUG

dosage is in oral form titrated to target trough level

1; 2

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Your child may be eligible for this study if he/she:
• Has received a kidney transplant.
• Has experienced 1 or more episodes of acute rejection or chronic rejection; a rejection episode must have responded to treatment and have occurred at least 30 days before study enrollment.
• Has stable kidney function at the time of study enrollment.
• Is 20 years of age or younger.
• Has written informed consent of parent or guardian if under the age of 18.
• Agrees to use birth control during the study and for 3 months following treatment.

You may not qualify if:

• Your child will not be eligible for this study if he/she:
• Has a history of cancer.
• Has received a multi-organ transplant (more than a kidney).
• Has an active infection.
• Has an abnormal chest X-ray.
• Cannot provide a kidney biopsy at time of study entry.
• Is allergic to sirolimus.
• Has received experimental drugs within 4 weeks of study entry.
• Is pregnant.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Children's Hospital Boston

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Cyclosporine; Sirolimus; Tacrolimus

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Macrolides; Lactones; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Division of Nephrology

Study Record Dates

• First Submitted: April 14, 2000
• First Posted: August 31, 2001
• Study Start: July 1, 1999
• Primary Completion: July 1, 2004
• Study Completion: March 1, 2006
• Last Updated: March 13, 2012

Record last verified: 2012-03

Locations

US (1)