Clinical Trials Logo
  1. Home
  2. Renal Transplant Recipients
  3. NCT00319189
  4. Details
NCT00319189 Clinical Trial

Efficacy and Safety of Nateglinide Treatment in Renal Transplant Recipients

Renal Transplant Recipients Clinical Trial

Official title:
Efficacy and Safety of Nateglinide Treatment in Renal Treatment Recipients With Post Transplant Diabetes Mellitus or Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00319189
Other study ID # Starlix in RTR
Secondary ID
Status Completed
Phase Phase 4
First received April 27, 2006
Last updated May 9, 2006
Start date November 2002
Est. completion date November 2003

Study information
Verified date April 2006
Source University of Oslo School of Pharmacy
Contact n/a
Is FDA regulated No
Health authority Norway: Directorate of Health
Study type Interventional

Clinical Trial Summary

The objective of the present study is to evaluate both the efficacy and safet of nateglinide in renal transplanta recipients with posttransplant diabetes mellitus or impaired glucose tolerance. Primarily will the change in glucose tolerance and acute insuline responce be addressed.

Recruitment information / eligibility
Status Completed
Enrollment 15
Est. completion date November 2003
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Reduced glucose tolerance (fasting glucose < 6.1 mmol/L AND 2 hour glucose between 6.7 and 9.9 mmol/L) or posttransplant diabetes mellitus (fasting glucose > 6.1 mmol/L OR 2 hour glucose between >= 10.0 mmol/L)

- Stable patients fgollowing renal transplantation, less than 25% variation in serum creatinine last week and serum creatinine < 200 micromol/L

Exclusion Criteria:

- Patients with indulin dependent diabetes mellitus before or after transplantation

- Planned change in daily prednisolone dose during the study period

- Haemoglobin < 8g/dL

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nateglinide

Locations
Country Name City State
Norway Rikshospitalet, Section of Nephrology Oslo

Sponsors (1)
Lead Sponsor Collaborator
University of Oslo School of Pharmacy

Country where clinical trial is conducted

Norway, 

Outcome
Type Measure Description Time frame Safety issue
Primary Glucose tolerance
Primary Insuline release
Secondary Glucose oxidation
Secondary Postprandial hyperlipidemia
Secondary Glomerular filtration rate
Secondary HbA1C
Secondary Fasting glucose
Secondary Plasma nitric oxide
Secondary Plasma endothelin-1
See also
  Status Clinical Trial Phase
Terminated NCT02956005 - Envarsus XR in African American Renal Transplant Recipients N/A
Completed NCT01086904 - Safety and Efficacy of an Inactivated and Non Adjuvanted Vaccine Against Influenza A in Renal Transplant Recipients Phase 2
Completed NCT01859832 - Validation of a Novel Diagnostic Tool for the Evaluation of Post Renal Transplant Immunosuppression: The ImmuKnow Assay N/A
Recruiting NCT03110406 - Effects of Whole-body Vibration Training on the Heart Rate Variability Cardiac in Kidney Transplantation N/A
Recruiting NCT02973464 - The Strategy in the Prevention of Renal Post-transplant Cytomegalovirus Infection Among Chinese Population Phase 3
Active, not recruiting NCT03797196 - RCT Comparing Immunosuppressive Regimens in Elderly Renal Transplant Recipients Phase 4
Terminated NCT01318915 - Research Study of ATG and Rituximab in Renal Transplantation Early Phase 1
Recruiting NCT00327483 - Web Based Renal Transplant Patient Medication Education Phase 4
Terminated NCT00271830 - Sexual Function in Male Renal Transplant Patients N/A
Completed NCT00138970 - Calcineurin Inhibitor-Free Immunosuppression in Renal Transplant Recipients at Low Immunogenic Risk Phase 4
Withdrawn NCT04903054 - Selective CD28 Blockade in Renal Transplant Recipients Phase 2
Completed NCT02706678 - Efficacy and Safety Study of the Switch From Cyclosporin to Tacrolimus in Renal Transplant Recipients Phase 4
Active, not recruiting NCT04218721 - Implementing eHealth Interventions Into Regular Clinical Practice N/A
Recruiting NCT03726307 - Allogeneic Regulatory Dendritic Cell (DCreg) Renal Study Phase 1