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Trial record 85 of 761 for:    region | Chile

Steroid Withdrawal in Pediatric Renal Transplant: Impact on Growth, Bone Metabolism and Acute Rejection

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ClinicalTrials.gov Identifier: NCT00707759
Recruitment Status : Completed
First Posted : July 1, 2008
Results First Posted : November 10, 2015
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Maria Angela Delucchi Bicocchi, Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Kidney Diseases
Interventions Drug: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone
Drug: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title A: Withdrawal Steroids B: Control Steroids
Hide Arm/Group Description

Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Arms B: TAC + MMF + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Period Title: Overall Study
Started 14 14
Completed 12 12
Not Completed 2 2
Arm/Group Title A: Withdrawal Steroids B: Control Steroids Total
Hide Arm/Group Description

Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Arms B: TAC + MMF + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Total of all reporting groups
Overall Number of Baseline Participants 12 12 24
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 12 participants 24 participants
6.0  (3.3) 6.9  (3.9) 6.5  (3.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 12 participants 24 participants
Female
6
  50.0%
4
  33.3%
10
  41.7%
Male
6
  50.0%
8
  66.7%
14
  58.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Chile Number Analyzed 12 participants 12 participants 24 participants
12 12 24
Height Z-score  
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 12 participants 12 participants 24 participants
-2.5  (1.0) -2.0  (1.2) -2.3  (1.1)
1.Primary Outcome
Title Stimulation of Growth After 12 Months (Delta Z-score)
Hide Description [Not Specified]
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title A: Withdrawal Steroids B: Control Steroids
Hide Arm/Group Description:

Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Arms B: TAC + MMF + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Overall Number of Participants Analyzed 12 12
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.2  (0.2) 0.6  (0.1)
2.Secondary Outcome
Title Growth-factors (IGF-I, IGFBP-3) Bone Metabolism (FA, Ca/Cru, CaxP, 25(OH)VitD, FGF23, Klotho, PTH, DXA, pQCT) Insulin-sensitivity by ISI Method. Molecular Markers - Acute Rejection (FOXP3/IL-17). Acute Rejection Incidence/Protocol Renal Biopsy
Hide Description [Not Specified]
Time Frame 12 months
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A: Withdrawal Steroids B: Control Steroids
Hide Arm/Group Description

Arms A: TAC + MMF + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + Withdrawal Prednisone: Arms A: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + withdrawal steroids over a six-days following randomization.

1°day: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

2ºday: Methylprednisolone iv, 2-3 mg/kg/d 3 doses

3°day: Prednisone 2 mg/kg/d in 2 doses

4ºday: Prednisone 1 mg/kg/d in 2 doses

5ºday: Prednisone 0.5 mg/kg/d in 2 doses

6ºday: Prednisone 0.25 mg/kg/d in 2 doses

7ºday: Stop Prednisone

Arms B: TAC + MMF + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone: Arms B: Tacrolimus (TAC)+ Mycophenolate Mofetil (MMF) + prednisolone (see schedule)/day

10°days after Tx: 2 mg/kg/d

Day 11 - 20: 1 mg/kg/d

Day 21 - 30: 0.5 mg/kg/d

Day 31 - 60: 0.3 mg/k/d

Week 8 - 12: 0.25 mg/k/d

Week 12 - 16: 0.20 mg/k/d

Week 16 - 20: 0.15 mg/k/d

Month 6 - 12: 0.10 - 0.12 mg/k/d

All-Cause Mortality
A: Withdrawal Steroids B: Control Steroids
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A: Withdrawal Steroids B: Control Steroids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A: Withdrawal Steroids B: Control Steroids
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/12 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Maria Angela Delucchi
Organization: FONDECYT
Phone: 56-2-25755972
Responsible Party: Maria Angela Delucchi Bicocchi, Fondo Nacional de Desarrollo Científico y Tecnológico, Chile
ClinicalTrials.gov Identifier: NCT00707759     History of Changes
Other Study ID Numbers: Fondecyt1080166
First Submitted: June 26, 2008
First Posted: July 1, 2008
Results First Submitted: October 13, 2015
Results First Posted: November 10, 2015
Last Update Posted: November 10, 2015