An Observational Study on Renal Function in Kidney Transplant Participants on Immunosuppressive Therapy Containing Mycophenolate Mofetil

NCT01672957 | Completed Results

• 1 other identifier: ML27844
• Study Type: observational
• Target: 128
• Locations: 1 country
• Sites: 2

Brief Summary

This observational study will evaluate renal function in participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil (CellCept). Eligible participants will be followed for 12 months following transplantation.

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (6)

• Creatinine Clearance at 1 Month After Transplantation

  Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 milliliters per minute (mL/min) and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

  Month 1

• Creatinine Clearance at Month 6 After Transplantation

  Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

  Month 6

• Creatinine Clearance at Month 12 After Transplantation

  Creatinine clearance is an indicator of renal function. Creatinine clearance is the volume of blood plasma that is cleared of creatinine by the kidneys per unit time. Normal values for healthy, young males are in the range of 100-135 mL/min and for females, 90-125 mL/min. Creatinine clearance decreases with age. A low creatinine clearance rate indicates poor kidney function.

  Month 12

• Glomerular Filtration Rate (GFR) at Month 1 After Transplantation

  GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is greater than (\>) 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR less than (\<) 15 mL/min indicates kidney failure.

  Month 1

• GFR at Month 6 After Transplantation

  GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.

  Month 6

• GFR at Month 12 After Transplantation

  GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. A normal GFR is \> 90 mL/min, although children and older people usually have a lower GFR. Lower values indicates poor kidney function. A GFR \< 15 mL/min indicates kidney failure.

  Month 12

Secondary Outcomes (4)

• Mean Dose of Mycophenolate Mofetil

  Baseline, Months 1, 6, and 12

• Percentage of Participants Who Received Other Immunosuppressive Agents in Combination With Mycophenolate Mofetil

  Baseline, Months 1, 6, and 12

• Percentage of Participants With Acute Rejection

  Baseline to Month 1, Months 2 to 6, Months 7 to 12

• Percentage of Participants With Graft Survival

  Months 1, 6, and 12

Study Arms (1)

Renal Transplant Participants

Renal transplant participants who will be subjected to a combined immunosuppressive treatment containing mycophenolate mofetil, will be followed-up until the end of the study (after 12 months), or until the participant's death, withdrawal, or lost contact with the participant, whichever occurs first. The choice of treatment will be made prior to enrolment by the treating physician. The treatment will be administered according to applicable therapeutic protocol and Summary of Product Characteristics (SmPC).

Drug: Mycophenolate Mofetil; Drug: Immunosuppressive Therapy

Interventions

Mycophenolate Mofetil DRUG

Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.

Also known as: CellCept

Renal Transplant Participants

Immunosuppressive Therapy DRUG

Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.

Renal Transplant Participants

Eligibility Criteria

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

Study Population

Renal allograft transplant participants initiated on combined immunosuppressive treatment containing mycophenolate mofetil

You may qualify if:

• Participants who underwent renal allograft transplantation and are started on combined immunosuppressive treatment containing mycophenolate mofetil in accordance with the indication provided by the SmPC of mycophenolate mofetil
• Date of study enrollment is the date of kidney transplantation

You may not qualify if:

• Contraindication included in the SmPC for capecitabine (Xeloda) prevailed, like: Hypersensitivity to active ingredient or any of the excipients of the product; Pregnancy and lactation

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (2)

Unknown Facility

Budapest, 1082, Hungary

Location

Unknown Facility

Pécs, 7624, Hungary

Location

MeSH Terms

Interventions

Mycophenolic Acid; Immunosuppression Therapy

Intervention Hierarchy (Ancestors)

Caproates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Fatty Acids; Lipids; Immunotherapy; Immunomodulation; Biological Therapy; Therapeutics; Immunologic Techniques; Investigative Techniques

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-La Roche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2012
• First Posted: August 27, 2012
• Study Start: September 1, 2011
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: October 11, 2016
• Results First Posted: October 11, 2016

Record last verified: 2016-08

Locations

HU (2)