Application of peripheral blood-derived stem cell (CD34?) therapy on chronic kidney disease

Phase 2

Completed

• Conditions: Chronic kidney disease; Urological and Genital Diseases

• Registration Number: ISRCTN15592135
• Lead Sponsor: Ministry of Science and Technology, Taiwan

Brief Summary

2020 Results article in https://pubmed.ncbi.nlm.nih.gov/32297703/ (added 20/01/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-22
• Study Completion: 2020-12-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 52

Inclusion Criteria

1. Aged 20-80 years old
2. Renal failure due to hypertension
3. Receiving optimal medical therapy (received optimal therapy for more than 12 weeks and have been evaluated by a nephrologist. Medication includes ACEI, ARB, DRI, beta-blocker or CCB. Blood pressure is less than 140/90 mmHg)
4. Renal function between chronic kidney disease (CKD) stage III-IV
5. Stable renal function maintained for 1 year before study (creatinine clearance rate between 15-60 ml/min and no significant changes)

Exclusion Criteria

1. Pregnant or breastfeeding
2. Infected with HIV
3. Infected with HBV or HCV
4. Myocardial infarction within 3 months prior to study
5. Heart failure (functional class IV)
6. Malignant or hematological disease
7. Severe disease with lifespan less than 1 year
8. End stage renal disease
9. Creatinine clearance rate less than 15 ml/min
10. Kidney disease on only one side
11. Participating in other clinical trials
12. Unable to receive therapies used in this study
13. Organ transplantation
14. Autoimmune disease

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of Ccr (creatinine clearance rate cc/min) from the baseline, assessed using serum creatine levels at the baseline, and after 1 week and 1, 3, 6, 9 and 12 months

Secondary Outcome Measures

Name	Time	Method
<br> 1. Reduction of proteinuria value (albumin/creatinine ratio), assessed at the baseline, and after 1 week and 1, 3, 6, 9 and 12 months. The albumin concentration per creatine level in urea is assessed using the microalbumin test and the urine protein/creatinine ratio is assessed by the Urine Protein-Creatinine Ratio (UPCR) test.<br> 2. Incidence of renal failure (either requiring haemodialysis or causing death) within the 1 year follow-up period<br>