Prednisone Withdrawal Versus Prednisone Maintenance After Kidney Transplant

• The Number of Participants With Acute Rejection Episodes [ Time Frame: 6 and 12 months post-transplant ] [ Designated as safety issue: No ]
  Acute rejection episodes would have been measured by the number of participants who underwent a kidney transplant biopsy, and had the results of the biopsy reported as acute rejection by the transplant pathologist. Biopsies were only performed if clinically indicated. The cumulative number of participants with recorded rejection episodes by 6 and 12 months post-transplant would have been reported.
  
  
• The Number of Participants With Graft Survival [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  The number of participants who did not experience graft failure (defined as return to dialysis) at 6 and 12 months would have been reported.
  
  
• Participant Survival [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  The number of participants alive at 6 and 12 months post-transplant would have been posted as a measure of patient survival.
  
  

• The Number of Participants With Treatment Failures [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  This measure was defined as the percentage of participants that did not remain on initial therapy (ie were withdrawn from each arm of the trial)
  
  
• Length of Hospital Stay After Transplant [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The length of the hospital stay would have assessed the number of days a participant was in the hospital after the kidney transplant was performed. This is calculated from date of admission to date of discharge.
  
  
• The Number of Participants With Hospital Readmissions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The number of readmissions during the study period for each participant would have been assessed, as well as the reason for readmissions.
  
  
• The Length of Stay Associated With Hospital Readmissions [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The time from admission to discharge for each readmission for patients readmitted in the first 12 months post-transplant.
  
  
• Participant Renal Function as Measured by MDRD Formula [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: Yes ]
  The above methods focus on estimating or determining actual glomerular filtration rate (GFR) (or renal function) of the kidney transplant. The MDRD (Modification of Diet in Renal Disease) calculation includes age, sex and serum creatinine would have provided an estimate of GFR. This was to be performed at 3,6 and 12 months post-transplant.
  
  
• Participant Renal Function as Measured by 24 Hour Urine Collection [ Time Frame: 3 and 12 months post-transplant ] [ Designated as safety issue: Yes ]
  Results would have been reported from patients undergoing 24 hour urine collections at 3 and 12 months post-transplant. This is a way to measure glomerular function rate (GFR) or renal function.
  
  
• The Number of Participants With the Need for Rabbit Antithymocyte Globulin to Treat Rejection Episodes. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The incidence and severity of rejection episodes per participant would have been identified by kidney transplant biopsy results read by a transplant pathologist. Treatment of rejection episodes in each participant would have been determined by the treating transplant physician.
  
  
• The Number of Participants With Leukopenia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  All participants would have been assessed for the presence at any time during the trial of: leukopenia (defined by lab results as a white count less than 3,000 cells/uL).
  
  
• The Number of Participants With Infections [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Participants would have been monitored throughout the study for any infectious complications as confirmed by the principal investigator. Patients would have been monitored by urine cytology and blood polymerase chain reaction for BK virus at baseline, and months 3, 6 and 12 post-transplant.
  
  
• The Number of Participants With Malignancy [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Participants would have been monitored throughout the study with any reports of malignancy being confirmed by principal investigator.
  
  
• The Number of Participants With Hypertension [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  The number of participants who developed hypertension defined as blood pressure greater than 140/90 throughout the first 12 months of the study.
  
  
• The Number of Participants With Hyperlipidemia [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Fasting lipid profiles were to be performed at 3,6 and 12 months post-transplant. Definitions based on ATP III guidelines.
  
  
• The Number of Participants With Bone Disease [ Time Frame: baseline (within 1 month post-transplant), 3, 6, 12 and 24 months ] [ Designated as safety issue: Yes ]
  Bone densitometry by Computed tomography of peripheral skeleton and DEXA scans were performed at baseline (within one month after transplant) Urine and blood samples to measure markers of bone turnover: Alkaline phosphatase, pyridinoline, serum 1-25 vit D 3 levels (calcitriol) and 25 hydroxy vit D (calcidiol) levels and serum osteocalcin levels were drawn at baseline, 3, 6, 12 and 24 months.
  
  
• The Number of Participants With Post Transplant Diabetes Mellitus [ Time Frame: pre-transplant in living donor recipients, baseline (within one month post-transplant) and at 3, 6 and 12 months ] [ Designated as safety issue: Yes ]

  Glucose tolerance test performed in non-diabetic participants only at pre transplant in living donor recipients and at baseline (within 1 mo after transplant) and 6 mo and 12 months. Blood test for hemoglobin A1C in non diabetic participants only: at baseline, 3, 6, and 12 months.

  Insulin and C peptide levels at baseline, 3,6 and 12 months in all participants.

  
  
• The Number of Participants With Weight Gain [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  Height, weight will be used to calculate change in BMI for all participants.
  
  

Corticosteroids (one specific type is prednisone) have been used in clinical transplantation for more than 30 years. There are many side effects of corticosteroids including significant bone disease, diabetes (elevated blood sugar levels), fluid retention and hypertension (high blood pressure), psychosis, peptic ulcer disease, hyperlipidemia (elevated lipid levels such as cholesterol and triglycerides), obesity (overweight), acne, and susceptibility to infections. It is hoped that the new generation of potent immunosuppressive medications (such as Prograf and CellCept) will permit avoidance or withdrawal of corticosteroids for the majority of patients to avoid both short- and long-term complications of corticosteroid use in kidney transplant recipients.