Gengraf Conversion Study in Stable Renal Allograft Transplant Recipients

NCT01990118 | Completed Phase 4 DMC

• 1 other identifier: 15.041
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to establish the therapeutic equivalence of Gengraf® with the standard treatment Neoral® for a treatment period of 6 months in stable renal allograft transplant recipients with respect to drug levels, dosage, and acute graft rejection and other adverse events.

Conditions

End Stage Renal Failure

Keywords

Renal transplant; Renal allograft rejection; Cyclosporine; Gengraf

Outcome Measures

Primary Outcomes (1)

• Serum creatinine level at 12 weeks

  Serum creatinine level at 12 weeks after conversion from Neoral to Gengraf

  at 12 weeks

Secondary Outcomes (1)

• CsA trough concentration and at 2 hour after CsA administration, at 2 weeks, 6 weeks 12 weeks, 6 months, 9 months and 12 months post randomization.

  weeks 2, 6, 12, months 6, 9 and 12.

Study Arms (2)

Neoral

ACTIVE COMPARATOR

Patients who continued to be treated with the drug Neoral.

Drug: Neoral

Gengraf arm

EXPERIMENTAL

Patients were randomly selected to be converted to 'Gengraf® capsule containing 25mg or 100mg cyclosporine'

Drug: Gengraf® capsule containing 25mg or 100mg cyclosporine

Interventions

Neoral DRUG

Neoral® capsule containing 25mg or 100mg cyclosporine

Also known as: Cyclosporine

Neoral

Gengraf® capsule containing 25mg or 100mg cyclosporine DRUG

Transplant patients who were stable on Neoral were converted to Gengraf

Also known as: Generic Cyclosporine

Gengraf arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent obtained from patient or parents/guardian.
• Patients who are more than 6 months post transplant
• Stable graft function i.e. serum creatinine less than 300 umol/l
• Patients currently on a stable dose of capsule Neoral within last one month

You may not qualify if:

• Multiple organ transplantation
• Pregnant or nursing woman, or women of childbearing potential without an effective method of birth control. Effective birth control methods are oral contraception, Norplant, surgical sterilization, Intra Uterine Device or diaphragms in conjunction with spermicidal foam and condom on the male partner.
• Participation in any drug trial in which the patient received an investigational drug within 30 days preceding the screening phase of this study.
• Those persons directly involved in the conduct of the study.
• Active infection at the time of screening for enrollment into trial.
• Acute graft rejection within the past 3 months
• Mentally unstable or history of mental diseases
• History of drug or alcohol abuse within the past 2 years.
• History of non-compliance to medical regimen and patients who are unwilling or unable to comply with the protocol.
• Decompensated liver disease
• Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study

Sponsors & Collaborators

• Penang Hospital, Malaysia: lead

Study Sites (1)

Clinical Research Centre, Penang Hospital

George Town, Pulau Pinang, 10990, Malaysia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Cyclosporine; Cyclosporins

Condition Hierarchy (Ancestors)

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)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr.Ong L Meng, MBBS, FRCP

  Penang Hospital, Ministry of Health Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant Nephrologist

Study Record Dates

• First Submitted: March 4, 2010
• First Posted: November 21, 2013
• Study Start: November 1, 2004
• Primary Completion: December 1, 2005
• Study Completion: May 1, 2006
• Last Updated: November 21, 2013

Record last verified: 2013-11

Locations

MY (1)