Trial Outcomes & Findings for Effect of Folic Acid and/or Pentoxifylline on Patients With Chronic Kidney Disease (NCT NCT05284656)
NCT ID: NCT05284656
Last Updated: 2025-06-11
Results Overview
Change was calculated as the value at 6 months minus the value at baseline.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
80 participants
Primary outcome timeframe
Baseline, 6 months
Results posted on
2025-06-11
Participant Flow
some patient are excluded from the study as they donnot meet the inclusion criteria
Participant milestones
| Measure |
Folic Acid Group
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
folic acid: drugs used to delay progression of chronic kidney disease
|
Pentoxifylline Group
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease
|
Folic Acid and Pentoxifylline Group
20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months
combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease
|
Control Group
20 patients will receive their standard therapy only.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
20
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Folic Acid Group
n=20 Participants
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
folic acid: drugs used to delay progression of chronic kidney disease
|
Folic Acid and Pentoxifylline Group
n=20 Participants
20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months
combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease
|
Pentoxifylline Group
n=20 Participants
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease
|
Control Group
n=20 Participants
20 patients will receive their standard therapy only.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52.25 years
STANDARD_DEVIATION 6.64 • n=20 Participants
|
51.80 years
STANDARD_DEVIATION 6.7 • n=20 Participants
|
52.20 years
STANDARD_DEVIATION 7.2 • n=20 Participants
|
51.6 years
STANDARD_DEVIATION 6.6 • n=20 Participants
|
51.96 years
STANDARD_DEVIATION 6.78 • n=80 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=20 Participants
|
16 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
53 Participants
n=80 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
27 Participants
n=80 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
glomular filtration rate
|
22.15 ml/min
STANDARD_DEVIATION 11.12 • n=20 Participants
|
17.25 ml/min
STANDARD_DEVIATION 7.217 • n=20 Participants
|
17.85 ml/min
STANDARD_DEVIATION 8.6 • n=20 Participants
|
21.87 ml/min
STANDARD_DEVIATION 9.7 • n=20 Participants
|
19.78 ml/min
STANDARD_DEVIATION 9.15 • n=80 Participants
|
PRIMARY outcome
Timeframe: Baseline, 6 monthsChange was calculated as the value at 6 months minus the value at baseline.
Outcome measures
| Measure |
Folic Acid Group
n=20 Participants
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
folic acid: drugs used to delay progression of chronic kidney disease
|
Pentoxifylline Group
n=20 Participants
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease
|
Folic Acid and Pentoxifylline Group
n=20 Participants
20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months
combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease
|
Control Group
n=20 Participants
20 patients will receive their standard therapy only.
|
|---|---|---|---|---|
|
Change in Serum Creatinine Level
|
3.118 mg/dl
Standard Deviation 1.203
|
3.335 mg/dl
Standard Deviation 1.149
|
3.535 mg/dl
Standard Deviation 0.9109
|
2.872 mg/dl
Standard Deviation 0.8901
|
SECONDARY outcome
Timeframe: 6 monthsincrease in serum ferritin from baseline
Outcome measures
| Measure |
Folic Acid Group
n=20 Participants
20 patients will receive folic acid 500 µg per day with their standard therapy for 6 months.
folic acid: drugs used to delay progression of chronic kidney disease
|
Pentoxifylline Group
n=20 Participants
20 patients will receive Pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months.
Pentoxifylline 400 MG: drugs used to delay progression of chronic kidney disease
|
Folic Acid and Pentoxifylline Group
n=20 Participants
20 patients will receive combination therapy of folic acid5 mg per day and pentoxifylline ( TRENTAL® Tablets, 400 mg) twice daily with their standard therapy for 6 months
combination of Pentoxifylline 400 MG and Folic Acid: drugs used to delay progression of chronic kidney disease
|
Control Group
n=20 Participants
20 patients will receive their standard therapy only.
|
|---|---|---|---|---|
|
Serum Ferritin in ng/ml
|
200.6 ng/ml
Standard Deviation 66.18
|
334.1 ng/ml
Standard Deviation 230.2
|
245.1 ng/ml
Standard Deviation 115.7
|
235.3 ng/ml
Standard Deviation 185.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthschange in Protein/ creatinine ratio for determination of proteinuria
Outcome measures
Outcome data not reported
Adverse Events
Folic Acid Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pentoxifylline Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Folic Acid and Pentoxifylline Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place