A Phase 4 interventional study of Epoetin alfa in Anemia and Renal Failure, Chronic Renal Failure, sponsored by Janssen Cilag S.A.S.. Terminated. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2011-05-17.
Sponsored by Janssen Cilag S.A.S. (part of Johnson & Johnson) · Phase 4, Interventional, and Treatment
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Among 126 studies testing Epoetin Alfa in Anemia — 2 open to participants now, 3 under way, 2 of them phase 3. Epoetin Alfa · Anemia.
Among the 126 studies testing Epoetin Alfa in Anemia, this one is the 29th largest by enrollment of the 112 interventional ones that give a count, is one of 4 that started in 2001, is one of 20 in phase 4, and was the 71st registered.
1,810 studies on the registry are indexed under Anemia; 215 are open to participants now.
Browse Anemia studies →2 of the 126 studies testing Epoetin Alfa in Anemia are open now, in 1 country. Recruiting first, the newest first:
Services Hospital, Lahore · Sites in Pakistan
Ages 18–65
Geoff Block
Ages 18+
By country, each count listing its studies:
Epoetin Alfa: first FDA approval 1989 (EPOGEN/PROCRIT), first EMA approval 1997. What it is approved for, and how studies give it, is on its page →
Of the 122 Anemia studies recruiting now, 67 (55%) set no upper age limit and 37 (30%) stop at 75 or younger; 34 take children under 18; 23 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
126 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 4 · Phase 2 45 · Phase 3 46 · Phase 4 20
First in 1988; this study’s year is marked. 4 started in 2001.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 217 is above the median of 117 across 1,336 interventional studies indexed under Anemia.
Median enrollment 71 across the 112 interventional studies. Of the 114 that completed or were terminated, 23 (20%) have results posted.
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95 of 126 have an industry lead sponsor. The 10 most frequent:
This study is registered under Janssen Cilag S.A.S., one of the names counted as Johnson & Johnson. Under that name alone:
Janssen Cilag S.A.S. is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
77 studies in Anemia by Johnson & Johnson: none open now, none under way, none of them phase 3. Of 74 finished, 9 (12%) have results posted.
Among the 77 studies in Anemia by Johnson & Johnson, this one is the 16th largest by enrollment of the 62 interventional ones that give a count, is one of 2 that started in 2001, is one of 5 in phase 4, and was the 53rd registered.
Johnson & Johnson’s Anemia studies by the year they started, since 1988.
2 of the studies testing Epoetin Alfa in Anemia that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07565701Phase 3Geoff BlockSafety and Efficacy of a Phased Transition From Epogen to Three Times Weekly Oral Vadadustat for the Treatment of Anemia in Subjects Receiving In-Center Hemodialysis | 2027-04 |
| NCT07755683Services Hospital, LahoreEffect of Daprodustat and Epoetin Alpha on Anemia in Patients Not Undergoing Dialysis | 2027-02-28 |
Add all 2 to your calendar (.ics) → With an account.
Among the 126 studies testing Epoetin Alfa in Anemia, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Johnson & Johnson’s 77 in Anemia:
Nothing recorded among them since 2026-09-25.
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The purpose of the study is to assess the effect of an early and complete correction of anemia after treatment with epoetin alfa on the rate of progression of chronic renal failure (which involves improper functioning of the kidneys). It also assesses the effect of hemoglobin normalization (correction of anemia) on the need for renal (kidney) replacement therapy, quality of life, blood pressure control, hospital admissions, mortality, cardiovascular events, nutritional status and safety.
Epoetin alfa can increase hemoglobin levels in chronic renal failure patients (patients with persistent kidney dysfunction) resulting in minimal transfusion requirements and improved kidney function capacity. This study is a randomized (patients randomly divided into groups), multicenter, open-label (study drug is known to the patients) clinical trial to assess the effect of normalization of hemoglobin (defined as a hemoglobin level of 13-14 g/dL in women and 14-15 g/dL in men) on the rate of progression of chronic renal failure (persistent kidney dysfunction). The study duration is 40 months. The study is in two phases (Phase A = stabilization, Phase B = maintenance) with two patient groups (Group 1, Group 2) per phase. In Phase A (lasting 4 months) for patients in Group 1, hemoglobin is progressively increased to a target level. Phase A can be extended up to 6 months for Group 1 patients in whom the target hemoglobin (13-14 g/dL in women, 14-15 g/dL in men) is not reached. Patients in Group 2, hemoglobin is progressively increased up to 12 g/dL with epoetin alfa if it drops below 11 g/dL. For all patients in Phase A, Iron and vitamin deficiencies will also be corrected, and factors known to affect progression of renal failure (kidney dysfunction) will be optimized. In Phase B (lasting 36 months), effectiveness of anemia correction by epoetin alfa will be compared against non-correction (continued anemia) with regard to changes in kidney function. During this phase, patients will be maintained at the higher (Group 1) or lower (Group 2) target hemoglobin level. Safety data (including cardiovascular events, seizures, and hypertension) will be collected and monitored throughout the study. The hypothesis of the study is that correction of anemia may slow down kidney deterioration and progression of kidney failure to end-stage kidney disease that is caused by anemia-induced hypoxia, a state of oxygen deficiency in the kidney. Another hypothesis of the study is that genetic mutations (changes in the genes) may play a role in the progression of chronic renal failure. For those patients wishing to participate in this aspect of the study, blood samples will be collected for genomic DNA analysis and the results will be compiled to determine which genes are generally associated in the study population with kidney deterioration. Patients will receive epoetin alfa injections (25 to 100 IU/kg) under the skin 1 time per week. Dosage may be increased by 25 IU/kg increments to reach or maintain target hemoglobin, then dose maintained for study duration, as long as hemoglobin stays within range.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Rate of progression of chronic renal failure over 36 months as measured by at least 2 glomerular filtration rate assessments.
Need for renal replacement therapy; quality of life; blood pressure control; hospital admissions; mortality; cardiovascular events; nutritional status.
No study locations are listed for this record.
The record gives a start of Feb 2001 and a completion of Jun 2003. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2010. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epoetin Alfa