Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00189735
Other study ID # FG-778-02-60
Secondary ID
Status Completed
Phase Phase 2
First received September 12, 2005
Last updated April 15, 2008
Start date September 2003
Est. completion date October 2005

Study information

Verified date April 2008
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical DevicesFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Belgium: Federal Agency for Medicines and Health Products, FAMHPPoland: Ministry of HealthCzech Republic: State Institute for Drug ControlUnited Kingdom: National Health ServiceSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyItaly: Ministry of HealthAustria: Federal Ministry for Health and WomenSwitzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

A dose finding study to evaluate the safety and effectiveness of FK778 in kidney transplant patients


Recruitment information / eligibility

Status Completed
Enrollment 364
Est. completion date October 2005
Est. primary completion date October 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patient has end stage kidney disease or needs retransplantation (loss of graft for non-immunological reasons).

- Patient has been fully informed.

Exclusion Criteria:

- Patient has an immunological high risk and/or having a previous graft survival shorter than 1 year due to immunological reasons.

- Patient has significant liver disease.

- Cold ischemia time of the donor kidney >28 hours.

- Patient having uncontrolled concomitant infections and/or severe diarrhoea, vomiting, active upper gastro-intestinal tract malabsorption or active peptic ulcer.

- Patient has previously received or is receiving an organ transplant other than kidney.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Intervention

Drug:
FK778


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Astellas Pharma Inc Astellas Pharma Europe B.V.

Countries where clinical trial is conducted

Austria,  Belgium,  Czech Republic,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of biopsy-proven acute rejection over the first 24 weeks.
Secondary Efficacy:Incidence of and time to first biopsy-proven acute rejection over the first 24 weeks and after 1 year
Secondary Incidence of and time to first corticosteroid-resistant acute rejections over the first 24 weeks and after 1 year
Secondary Incidence of and time to first acute rejection by signs and symptoms over the first 24 weeks and after 1 year
Secondary Severity of biopsy-proven acute rejections (Banff criteria) over the first 24 weeks and after 1 year
Secondary Frequency of treatment failure (as defined below) over the first 24 weeks and after 1 year
Secondary Renal function as measured by serum creatinine concentrations and calculated creatinine clearance (Cockcroft formula) over the first 24 weeks and after 1 year
Secondary Chronic allograft dysfunction assessed by chronic allograft damage index (CADI) after 24 weeks of transplantation.
Secondary Safety first 24 weeks: Patient survival
Secondary Graft survival
Secondary Incidence of adverse events
Secondary Routine safety laboratory parameters
Secondary Haemoglobin values at weeks two to six
Secondary Leukocytes at weeks two to six
Secondary Thrombocytes at weeks two to six
Secondary Bilirubin at weeks two to six
Secondary Incidence of CMV viraemia
Secondary Incidence of Diarrhoea, Gastroenteritis and Gastritis
Secondary Safety after 1 year:Incidence of adverse events
Secondary Patient and graft survival
See also
  Status Clinical Trial Phase
Recruiting NCT04910867 - APOL1 Genetic Testing Program for Living Donors N/A
Completed NCT02723591 - To Compare the Effects of Immediate-release Tacrolimus and Astagraf XL on Donor-Specific Antibody (DSA) Formation and the Development of Immune Activation (IA) in de Novo Kidney Transplant Recipients Phase 4
Completed NCT05945511 - Silent Gallbladder Stone in Kidney Transplantation Recipients: Should it be Treated?
Completed NCT02234349 - Bile Acids and Incretins in Pancreas Kidney Transplant Patients N/A
Completed NCT04496401 - PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus Phase 4
Recruiting NCT05917795 - Endoscopic Sleeve Gastroplasty With Endomina® for the Treatment of Obesity in Kidney Transplant Candidates N/A
Not yet recruiting NCT05934383 - Safety and Efficacy of Ultrasound Renal Denervation in Kidney Transplantation Patients With Uncontrolled Hypertension N/A
Withdrawn NCT04936971 - Introduction of mTor Inhibitors and the Activation of the Cytomegalovirus (CMV) -Specific Cellular Immune Response Phase 4
Not yet recruiting NCT04540640 - Oxygenated Machine Preservation in Kidney Transplantation N/A
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Recruiting NCT02908139 - Noninvasive Perioperative Monitoring of Arterial Stiffness, Volume and Nutritional Status in Stable Renal Transplant Recipients N/A
Terminated NCT02417870 - Ultra-low Dose Subcutaneous IL-2 in Renal Transplantation Phase 1/Phase 2
Completed NCT02560558 - Bela 8 Week Dosing Phase 4
Recruiting NCT02154815 - Pre-emptive Kidney Transplantation Quality of Life N/A
Completed NCT02235571 - iChoose Decision Kidney Aid for End-Stage Renal Disease Patients N/A
Enrolling by invitation NCT01905514 - ImPRoving Adherence to Immunosuppressive Therapy by Mobile Internet Application in Solid Organ Transplant Patients N/A
Completed NCT02147210 - Chronic Transplant Glomerulopathy and Regulation of Expression of Ephrin B1 N/A
Recruiting NCT01699360 - The Biomarker for Immunosuppressive Agents Metabolism in Chinese Renal Transplant Recipients Phase 4
Terminated NCT01436305 - Optimization of NULOJIX® Usage As A Means of Avoiding CNI and Steroids in Renal Transplantation Phase 2
Completed NCT01672957 - ORANGE Study: An Observational Study on Renal Function in Kidney Transplant Patients on Immunosuppressive Therapy Containing CellCept (Mycophenolate Mofetil) N/A