A Study of BMS-224818 (Belatacept) in Patients Who Have Undergone a Kidney Transplant and Are Currently on Stable Cyclosporine or Tacrolimus Regimen With or Without Corticosteroids

NCT00402168 | Completed Phase 2 Results DMC

• 2 other identifiers: IM103-010LEA29Y
• Study Type: interventional
• Target: 173
• Locations: 12 countries
• Sites: 44

Brief Summary

The purpose of this study is to learn if conversion to belatacept from cyclosporine or tacrolimus will preserve kidney function in people who have had a kidney transplant. The safety and tolerability of this treatment will also be studied

Conditions

Renal Transplant

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 12 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)

  Calculated GFR assessment used the modification of diet in renal disease (MDRD) formula. GFR was measured as mL/min/1.73 m\^2. For death or graft loss participants, calculated GFR (cGFR) value 10 was used, for other participants who had a post baseline cGFR value missing, but had baseline value and at least 2 post baseline values available, which were at least 120 days apart, linear regression model was used to impute the cGFR value. Baseline = value at screening. Randomization/First Dose was on Day 1.

  Baseline to 12 months post randomization

Secondary Outcomes (25)

• Mean Change From Baseline in Calculated Glomerular Filtration Rate (GFR) With Imputed Values to 6 Months Post Randomization - All Randomized Participants (Intent-to-Treat Population)

  Baseline to 6 months post randomization

• Number of Participants With Acute Rejection (AR) by Months 6 and 12 Post Randomization - All Randomized Participants

  At 6 and 12 months post randomization

• Percentage of Participants Surviving With a Functioning Graft, Have Graft Loss or Death (Graft Loss, Death, Death With Functioning Graft) By Month 6 and Month 12 Post Randomization

  At 6 and 12 months post randomization

• Number of Participants Who Had Any Study Drug Dose Alteration by Month 12 Due to Any Reason - Randomized and Treated Participants

  Month 12

• Percentage of Participants With a Composite Endpoint of Death, Graft Loss and Acute Rejection at Month 12

  12 Months post randomization

Study Arms (2)

A: Belatacept

EXPERIMENTAL

Drug: Belatacept

B: calcineurin inhibitor (CNI)-based immunosuppressive regimen

ACTIVE COMPARATOR

Drug: Cyclosporine A; Drug: Tacrolimus

Interventions

Belatacept DRUG

IV, IV Infusion, 5 mg/kg once every 28 days for one year

Also known as: BMS-224818

A: Belatacept

Cyclosporine A DRUG

Tablets, Oral, Trough of 100-250 ng/mL, 2\* daily for one year

B: calcineurin inhibitor (CNI)-based immunosuppressive regimen

Tacrolimus DRUG

Tablets, Oral, Trough of 5-10 ng/mL, 2\* daily for one year

B: calcineurin inhibitor (CNI)-based immunosuppressive regimen

Eligibility Criteria

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

You may qualify if:

• Men and women age 18 and older
• months after kidney transplant receiving cyclosporine or tacrolimus
• calculated GFR ≥35 and ≤75mL/min/1.73 m²
• subjects must have completed 1 year in the IM103-010ST and remained on study treatment (Long Term Extension)

You may not qualify if:

• Significant infection
• acute rejection within 3 months
• prior graft loss due to rejection
• pregnancy
• positive crossmatch

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (44)

Mayo Clinic Hospital

Phoenix, Arizona, 85054, United States

Location

National Institute Of Transplantation

Los Angeles, California, 90057, United States

Location

California Institute Of Renal Research

San Diego, California, 92123, United States

Location

Ucsf

San Francisco, California, 94143-0106, United States

Location

University Of Chicago

Chicago, Illinois, 60637, United States

Location

Pharmacy, First Call Iv

Kenner, Louisiana, 70062, United States

Location

Tulane University Hospital & Clinic

New Orleans, Louisiana, 70112, United States

Location

University Of North Carolina School Of Medicine

Chapel Hill, North Carolina, 27599-7155, United States

Location

Medical College Of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Local Institution

Buenos Aires, Buenos Aires, 1155, Argentina

Location

Local Institution

Capital Federal, Buenos Aires, C1425APQ, Argentina

Location

Local Institution

Córdoba, Córdoba Province, 5016, Argentina

Location

Local Institution

Rosario, Santa Fe Province, 2000, Argentina

Location

Local Institution

Santa Fe, Santa Fe Province, S3000EPV, Argentina

Location

Local Institution

Parkville, Victoria, 3050, Australia

Location

Local Institution

Brussels, 1070, Belgium

Location

Local Institution

Edegem, 2650, Belgium

Location

Local Institution

Curitiba, Paraná, 80240-000, Brazil

Location

Local Institution

Bonsucesso, Rio de Janeiro, 21041-030, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90020-090, Brazil

Location

Local Institution

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Local Institution

São Paulo, São Paulo, 01323-900, Brazil

Location

Local Institution

Edmonton, Alberta, T6G 2G3, Canada

Location

Local Institution

Halifax, Nova Scotia, B3H 1V8, Canada

Location

Local Institution

Hamilton, Ontario, L8N 4A6, Canada

Location

Local Institution

Saskatoon, Saskatchewan, S7M 0Z9, Canada

Location

Local Institution

Paris, Cedex 15, 75743, France

Location

Local Institution

Toulouse, Cedex 09, France

Location

Charite Berlin Mitte

Berlin, 10117, Germany

Location

Local Institution

Homburg/saar, 66421, Germany

Location

Local Institution

Pāladi, Ahmedabad, 380007, India

Location

Local Institution

Nadiād, Gujarat, 387001, India

Location

Local Institution

Kochi, Kerala, 682304, India

Location

Local Institution

Aguascalientes, Aguascalientes, 20000, Mexico

Location

Local Institution

Df, Mexico City, 14000, Mexico

Location

Local Institution

Cuernavaca, Morelos, 62448, Mexico

Location

Local Institution

San Luis Potosí City, Snl, 78240, Mexico

Location

Local Institution

Tlalpan, C P, 14080, Mexico

Location

Local Institution

Bydgoszcz, 85-094, Poland

Location

Local Institution

Szczecin, 70-111, Poland

Location

Local Institution

Warsaw, 02-006, Poland

Location

Local Institution

Barcelona, 08026, Spain

Location

Local Institution

Barcelona, 08907, Spain

Location

Local Institution

Valencia, 46017, Spain

Location

Related Publications (1)

• Rostaing L, Massari P, Garcia VD, Mancilla-Urrea E, Nainan G, del Carmen Rial M, Steinberg S, Vincenti F, Shi R, Di Russo G, Thomas D, Grinyo J. Switching from calcineurin inhibitor-based regimens to a belatacept-based regimen in renal transplant recipients: a randomized phase II study. Clin J Am Soc Nephrol. 2011 Feb;6(2):430-9. doi: 10.2215/CJN.05840710. Epub 2010 Nov 4.

  PMID: 21051752 DERIVED

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Interventions

Abatacept; Cyclosporine; Tacrolimus

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins; Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Macrolides; Lactones; Organic Chemicals

Limitations and Caveats

CNI arm discontinued Year 3, and those not switching treatment discontinued from study. No formal comparisons in calculated GFR were planned post Month 36, and these data up to the final database lock should be interpreted with caution.

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2006
• First Posted: November 22, 2006
• Study Start: January 1, 2007
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2013
• Last Updated: January 5, 2017
• Results First Posted: January 5, 2017

Record last verified: 2016-11

Locations

AU (1); BE (2); DE (2); FR (2); ES (3); AR (5); IN (3); PL (3); ME (5); CA (4); BR (5); US (9)